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regulatory affairs specialist

Envista Holdings

<div><p>Operating Company: DEXIS<br>
Location: Istanbul,Istanbul,TR<br>
Date Posted: November 11, 2025<br>
Req Number: R5024578</p></div><div></div>
<br><div><p><b>Job Description:</b></p> <p>Interprets federal/state/international regulations as they apply to our products, processes and/or procedures advises on impact of regulations, devises strategies for compliance, and liaison with regulatory bodies. Investigates and resolves compliance problems, questions and complaints. Audits and evaluates current policies, procedures, and documentation for compliance with regulations and statutes. Determine the need for and prepare regulatory submissions, negotiate the resolution of agency questions, and secure market clearance and/or approval and appropriate country licenses and certificates for new products and/or changes to existing products. Executes appropriately on product recalls. Respond to regulatory agency inquiries. Support the manufacturing lines when nonconformance exists to ensure appropriate regulatory assessments and requirements.</p><p> </p><p><b>Job Requirements:</b></p> <p><b>Reports to Role</b>: Head of RA Regions &amp; Registrations</p><p></p> <p><b>Location</b> (HQ or Region, Country, Site):</p> <p>Istanbul, Turkey, EH TURKEY SA&#286;LIK &Uuml;R&Uuml;NLER&#304; VE H&#304;ZMETLER&#304; L&#304;M&#304;TED &#350;&#304;RKET&#304;. Fully remote</p><p></p> <p><b><i>PURPOSE </i></b><i>&ndash; in a few sentences, briefly describe the overall purpose of the role, i.e. why the role exists</i></p> <p>The Regulatory Affairs Specialist supports regulatory affairs activities for international product registration by providing regulatory documentation and stakeholder support to ensure the timely regulatory approvals and maintenance of products in compliance with local regulatory requirements.</p><p></p> <p>The Regulatory Affairs Specialist is accountable for timely execution of regulatory strategies to support launch activities and maintain compliance status for international product registration.</p> <p><b><i>ACCOUNTABILITIES </i></b><i>&ndash; describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following:</i></p> <p>The Regulatory Affairs Specialist is accountable for compliance and delivery for all assigned countries and registrations in Regions.</p> <p><b>Regions &amp; Registrations</b></p><ul> <li>Contribute to development and execution of regulatory strategies for respective department projects, compliance projects as well as lifecycle management activities.</li> <li>Contribute to execution of International RA support projects for market access to REGIONS and ensure all RA related elements &amp; requirements implemented.</li> <li>Align with local distributors and with local RA, understand requirements, and assists with the deliverables/ files related to preparing ROW submissions; uploads deliverables/ files into repository. Consults with others on these efforts as required.</li> <li>Prepare, order, and maintain oversight of all Free Sales Certificates, Certificates of Foreign Government and Country of Origin certificates requested for international regulatory approvals</li> <li>Prepare core documentation &quot;regulatory submission packages&quot; for new product registrations in international markets</li> <li>Prepare country specific documents for international regulatory approvals including, but not limited to manufacturer statements, Letters of Authorization and Power of Attorney</li> <li>Review submission documents prepared by local RA to be used in country registrations</li> <li>Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes</li> <li>Conduct regulatory release and delisting of products using specialized regulatory software</li> <li>Is aware of procedures and only makes decisions in line with procedure on simple topics</li> <li>Plan out workload to deliver on time, able to make adjustments when required and prioritizing work together with manager</li> <li>Prepare, and follow-up on International regulatory assessments for product changes</li> <li>Closely monitoring together with local country representatives guidelines, regulations, changes in the marketplace and regulator positions for the assigned markets to ensure new requirements are caught, impact assessed and escalated if required</li> <li>Close gaps created due to changed or new local country requirements by initatin projects and/or incorporating into global processes.</li></ul><ul> <li>Support the provision of regulatory guidance to project teams in assigned projects and markets, in terms of requirements and related submission to support optimal timelines and required compliance levels.</li></ul><ul> <li>Support the assembly of documents and the submission to authorities in countries of responsibility</li> <li>Supports the monitoring of the regulatory environment and maintenance of the information resources</li> <li>Support internal and external audits in the audit preparation and audit back office</li> <li>Contributes and participates in the review of change requests to ensure compliance and the potential for regulatory submissions</li> <li>May assist with reviews of promotional materials.</li> <li>Has a yearly training program in place specified by manager.</li> <li>Support the creation and maintenance of regulatory procedures and templates.</li> <li>Can revise or create Technical Files.</li> <li>Support the review of labels and IFUs</li> <li>Support provision of regulatory guidance for Nobel Biocare IFU and labeling processes</li> <li>Tracks and maintains files on current status of licenses, registrations and product information as per agreed formats in the different systems in use by the organization</li> <li>Can collect the regulatory compliance status of main countries, contribute to regulatory status of other regions of devices affected by HHE/Deviation/CAPA/Recall.</li> <li>Provide internal trainings on requirements for area under their responsibility.</li> <li>Knows and understands the EBS philosophy and employs it in daily RA activities and standard work.</li> <li>Able to provide input in terms of activities required to be added to a DM or VPM.</li> <li>Trained on PSP procedures to solve standard problems; analyzes information and standard practices to make judgments.</li></ul> <p><b><i>KNOWLEDGE, SKILLS &amp; EXPERIENCE </i></b><i>&ndash; </i><i>Functional/technical competencies specific to the role and required to perform the role</i></p> <p><b>Critical Knowledge and Qualifications: </b><i>(what the role holder must know; including any required general or professional qualifications/education)</i></p><ul> <li>A minimum of a Bachelor&rsquo;s degree from accredited college or university is required.</li> <li>Basic knowledge of medical device quality management systems such as 21 CFR Part 820 and ISO 13485.</li> <li>Basic knowledge of international legislation in some countries.</li> <li>Knowledge of main general documents required as FSC &amp; legalization process</li></ul> <p><b>Critical Skills/technical know-how: </b><i>(what the role holder must be able to do)</i></p><ul> <li>Fluency in English a must. Further languages is an advantage.</li> <li>Able to communicate effectively with team members, project team members, manager and other stakeholders; this includes: able to listen and grasp key information, able to clearly convey straightforward information, able to read non-verbal communication, such as reading body language and able to give short presentations to RA team on straightforward information</li> <li>Demonstrates and advocates for working together in the spirit of openness, honesty and transparency that encourages engagement, collaboration, respectful interactions and trust.</li> <li>Seeks out diverse ideas, opinions and insights, and applies them in workplace.</li> <li>Works closely with direct team and project teams and starts building up network of colleagues, stakeholders, SMEs and customers.</li> <li>Is aware of procedures and regulations and is able to assess situation on simple topics</li> <li>Creates clarity and direction amid complexity and develops solutions</li> <li>Never compromises on patient safety.</li> <li>Have a positive attitude and 'can do' spirit</li> <li>Ability to be flexible and adaptable. Maintain a professional demeanor under pressure.</li> <li>Demonstrate a commitment to getting the job done right and on time and prioritizing work together with manager.</li> <li>Be able to manage several projects, tasks products and/or countries work load and takes ownership.</li> <li>Have attention to detail to task in hand but also start seeing bigger picture / wider process.</li> <li>Know when to ask questions.</li></ul><p></p> <p><b>Critical Experience:</b></p><ul> <li>Minimum 2 years' experience in regulatory affairs or associated field within medical device industry.</li></ul> <h2 class="jobSectionHeader"><b>COMPETENCIES &ndash; Essential for the role</b></h2> <p><i>Determine max. 6 competencies, refer to List and Definition of Competencies</i></p><ul> <li>Continuous Improvement</li> <li>Planning and Organizing</li> <li>Strategy execution</li> <li>Driving Execution</li> <li>Learning Orientation</li> <li>Actively contribute to successful team</li></ul><p> </p><p><b>Operating Company:</b></p> <p>DEXIS</p> <p>Envista and its family of companies (Envista) will not accept unsolicited resumes from any source other than directly from a candidate. Envista will consider unsolicited referrals and/or resumes submitted by vendors such as search firms, staffing agencies, professional recruiters, fee-based referral services and recruiting agencies (Agency) to have been referred by the Agency free of charge and Envista will not pay a fee for any placement resulting from the receipt such unsolicited resumes. An Agency must obtain advance written approval from Envista's internal Talent Acquisition or Human Resources team to submit resumes, and then only in conjunction with a valid fully-executed contract approved by the Global Talent Acquisition leader and in response to a specific job opening. Envista will not pay a fee to any Agency that does not have such agreement and written approval in place.</p></div>

Regulatory Affairs Specialist

Perrigo

<p></p><div><p>At Perrigo, we are driven by our mission to <b><i>Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All</i></b>. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing <b><i>The Best Self-Care for Everyone</i></b>, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. <b>We Are Perrigo</b>. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.</p><p></p><p><br>
Join us on our One Perrigo journey as we evolve to win in self-care.</p><p></p><div><div><div><h2 class="jobSectionHeader"><b><br>
Description Overview</b></h2></div><div><p>
In this role you will be responsible for the hands on regulatory activities required to maintain existing commercial products, and support in making correct and timely new product applications of Perrigo products on the Turkish market. You will support to ensure compliance with the existing legislation for Medicines, Medical Devices, Biocides and Cosmetics. Another key aspect of the role will be supporting in the achievement of the overall Regulatory, Quality &amp; Safety objectives and timely realization of operational activities. In this position you collaborate closely with the Corporate Regulatory and Turkish Commercial colleagues to strive to help the customer the best.</p></div></div><div><div><h2 class="jobSectionHeader"><b>
Scope of the Role</b></h2></div><div><ul><li>
Support in the management of change by preparing applications and technical files in support of existing commercial product regulatory maintenance;</li><li>
Support in the regulatory activities on new product development (NPD), including artwork approvals, label claims and associated supporting documentation;</li><li>
Develop and approve label specifications (master text and local artwork text) in compliance with SOPs, as well as promotional materials from a regulatory perspective;</li><li>
Maintain regulatory files and data systems in compliance with SOPs;</li><li>
Represent regulatory affairs in project meetings with both Perrigo staff and external contacts;</li><li>
Follow up on changes in (inter)national regulations and legislations, and support in the interpretation, communication and implementation;</li><li>
Liaise with Corporate Regulatory, responding to regulatory queries and providing and review of registration documents as necessary for the Turkish and/or European territory;</li><li>
Support in the communication with local regulatory authorities regarding license applications and notice of change.</li></ul></div></div><div><div><h2 class="jobSectionHeader"><b>
Experience Required</b></h2></div><div><ul><li>
University Degree in a Scientific Subject;</li><li>
Minimum of 2 years work experience within Regulatory Affairs required, within at least one of the following categories Medical Devices, Biocides, Cosmetics and Medicines;</li><li>
Excellent communicator in Turkish and English;</li><li>
Proficient computer skills esp. Microsoft (word, excel, powerpoint); experience with Veeva, TVT, Trackwise is an asset;</li><li>
Eye for detail, punctual, well organized;</li><li>
Being flexible and adaptable to change;</li><li>
Ability to support several concurrent projects/products simultaneously;</li></ul></div></div></div><p><b>
Benefits</b><br>
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.</p><p>
Find out more about <b>Total Rewards</b> at Perrigo.</p><p></p><p><b><br>
Hybrid Working Approach</b><br>
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.</p><p></p><p><br>
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more <b>here</b></p><p></p><p><b><br>
Applicants please note:</b> To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.</p><p></p><p><i><br>
We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law. #weareperrigo</i></p></div>

Regulatory Affairs, Associate Specialist

Manpower Türkiye

<div>
 <p>
  We are looking for a
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   "Regulatory Affairs Assistant to Specialist"
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  on behalf of a client to whom we provide consultancy services, operating in the hearing aids and medical equipment industry.
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   Job Definition
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  &bull; Support the preparation, review, and submission of regulatory documentation in compliance with local and international requirements.
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  &bull; Assist in maintaining regulatory files and product registration databases.
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  &bull; Support audit and inspection preparation activities as needed.
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  &bull; Collaborate effectively with different business teams to ensure smooth regulatory processes and timely submissions.
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   Qualifications
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  &bull; Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, Chemistry, Biology, or a related life sciences field.
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  &bull; Up to 1 year of professional experience in Regulatory Affairs or related areas in medical device sector.
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  &bull; Strong communication and coordination skills, with the ability to work effectively across departments.
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  &bull; Excellent attention to detail and organizational skills.
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  &bull; Fluency in English (both written and spoken) is required.
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  &bull; Proficiency in MS Office applications.
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   Please note that only the candidates that fulfill these requirements will be considered and shortlisted candidates will be contacted. LinkedIN &uuml;zerinden elektronik olarak iletece&gbreve;iniz ki&scedil;isel bilgileriniz, 6698 say&inodot;l&inodot; Ki&scedil;isel Verilerin Korunmas&inodot; Kanunu ve ilgili mevzuat &ccedil;er&ccedil;evesinde, Experis T&uuml;rkiye (Manpower Group T&uuml;rkiye) taraf&inodot;ndan yaln&inodot;zca &Scedil;irketimizden talep etti&gbreve;iniz hizmetlerin sunulabilmesi ve bu hizmetlerin s&uuml;reklili&gbreve;inin sa&gbreve;lanmas&inodot; ama&ccedil;lar&inodot;yla saklanabilecek, i&scedil;lenebilecek ve verilen servisin gerektirdi&gbreve;i hallerde yurti&ccedil;inde ve yurtd&inodot;&scedil;&inodot;nda yerle&scedil;ik 3. ki&scedil;ilerle payla&scedil;&inodot;labilecek olup, ki&scedil;isel verileriniz hi&ccedil;bir &scedil;ekilde hukuka ve d&uuml;r&uuml;stl&uuml;k kural&inodot;na ayk&inodot;r&inodot; &scedil;ekilde ba&scedil;kalar&inodot; ile payla&scedil;&inodot;lmayacak ve i&scedil;leme sebebi d&inodot;&scedil;&inodot;nda ba&scedil;ka ama&ccedil;larla kullan&inodot;lmayacakt&inodot;r. Ki&scedil;isel verileriniz yaln&inodot;zca i&scedil;leme amac&inodot;n&inodot;n gerekli k&inodot;ld&inodot;&gbreve;&inodot; s&uuml;re boyunca saklanacak olup talebiniz &uuml;zerine silinecek veya imha edilecektir. Detayl&inodot; bilgiye https://www.experis.com.tr/site/kisisel-verilerin-korunmasi/39 linkinden ula&scedil;abilirsiniz. Bu i&scedil;e ba&scedil;vurarak, &ouml;zge&ccedil;mi&scedil;inizin veritaban&inodot;m&inodot;zda yer almas&inodot;n&inodot; kabul etmi&scedil; oldu&gbreve;unuzu bildirmek isteriz.
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Regulatory Affairs Assistant to Specialist

Roche

<div><p>At Roche you can show up as yourself, embraced for the unique qualities you bring. Our culture encourages personal expression, open dialogue, and genuine connections, where you are valued, accepted and respected for who you are, allowing you to thrive both personally and professionally. This is how we aim to prevent, stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche, where every voice matters.</p><p></p><div>
The Position</div><p>
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people&rsquo;s varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.<br>
<br>
The Position<br>
We are looking for a Regulatory Affairs and Quality Specialist at Roche Diagnostics.<br>
 <b>What will you do?</b></p><ul><li><p><br>
You ensure all product related local and global requirements for registration.</p></li><li><p><br>
You supervise all kinds of registration procedures of the products, to obtain documentation related there of from company&rsquo;s relevant global functions. Mastery of all IVD product local registration processes and coordination with functions such as product management, sales and tenders.</p></li><li><p><br>
You coordinate regulatory documentation activities, obtain overseas documents required for tenders and other legal procedures and participate meetings with regulatory body when necessary.</p></li><li><p><br>
You update and maintain the quality assurance system aligned with global standards and local requirements.</p></li><li><p><br>
You work together with distributors in the quality assurance area and to perform controlling processes when necessary.</p></li><li><p><br>
You prepare internal and external audits in collaboration with internal stakeholders and perform the action plans.</p></li></ul><p><b><br>
Who are you?</b></p><ul><li><p><br>
You have University Degree</p></li><li><p><br>
You have Regulatory affairs and Quality experience in IVD/medical device industry</p></li><li><p><br>
You have process knowledge and experience in ISO 9001 and ISO 13485 standards</p></li><li><p><br>
You are experienced in conducting 2nd party audits &amp; 3rd party logistics processes</p></li><li><p><br>
You are proactive and team worker.</p></li><li><p><br>
You are Fluent in English</p></li></ul><p></p><div>
Who we are</div><p>
A healthier future drives us to innovate. Together, more than 100&rsquo;000 employees across the globe are dedicated to advance science, ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities, foster creativity, and keep our ambitions high, so we can deliver life-changing healthcare solutions that make a global impact.</p><p><br>
Let&rsquo;s build a healthier future, together.</p><p></p><p><b>
Roche is an Equal Opportunity Employer.</b></p></div>

Quality & Regulatory Specialist

Gilead Sciences

<div>
 At Gilead, we&rsquo;re creating a healthier world for all people. For more than 35 years, we&rsquo;ve tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer &ndash; working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world&rsquo;s biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference.
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 <br/>
 Every member of Gilead&rsquo;s team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we&rsquo;re looking for the next wave of passionate and ambitious people ready to make a direct impact.
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 We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together.
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 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 Regulatory Affairs Manager Turkiye; is responsible from managing RA submissions &amp; supporting Clinical Trials applications and will serve as a core member of the affiliate Regulatory Team interacting with local Regulatory Authorities and other stakeholders to ensure that the company complies with country&rsquo;s applicable legislations.
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  Knowledge &amp; Details
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   Manage regulatory submissions to local HA submissions inc. but not limited to Pre-MAA related activities (GMP &amp; prioritization applications), marketing Authorisation (MA) applications &amp; variations and other MA maintenance applications, in line with local HA expectations, Gilead SOPs and business objectives for assigned product(s) or projects.
  </li>
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   Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.
  </li>
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   Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.
  </li>
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   Manage clinical trial applications, amendments, and notifications. Collaborate with Clinical Operations and the CT Hub to complete CT submissions to MOH timely and interacts with cross-functional teams internally and externally to ensure submission package fulfils the MoH requirements on time.
  </li>
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   Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
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   Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
  </li>
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   Ensure good and strong relationships with functional areas of the local organization (Medical Affairs, Commercial, Market Access, Legal, etc.) and with Gilead Sciences Global/Regional RA in order to ensure the success of local and international business results from the regulatory point of view.
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   Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
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   Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
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   Actively contribute to local and global initiatives that improve regulatory processes.
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   <br/>
  </li>
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  Professional Experience / Key Skills
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   Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
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   Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
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   Proven ability to prioritize, conduct, and manage time to meet project deadlines.
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   Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
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   Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
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   Strong focus on achievement of goals and continuous improvement
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   Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
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   Having excellence in multiple project management, good communication and interpersonal skills.
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   Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
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   Team player who actively contributes to the team in order to complete tasks, meet goals or manage projects, actively listen others, respect ideas and aim to improve the process.
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   Fluency in spoken and written English.
  </li>
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   Good decision-making skills are important.
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   Excellent verbal, written, organization skills and interpersonal communication skills required.
   <br/>
   <br/>
  </li>
 </ul>
 Equal Employment Opportunity (EEO)
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 <br/>
 It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively "Gilead" or the "Company") to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law, all employment actions relating to issues such as compensation, benefits, transfers, layoffs, returns from layoffs, company-sponsored training, education assistance, social and recreational programs are administered on a non-discriminatory basis (i.e. without regard to protected characteristics or prohibited grounds, which may include an individual&rsquo;s gender, race, color, national origin, ancestry, religion, creed, physical or mental disability, marital status, sexual orientation, medical condition, veteran status, and age, unless such protection is prohibited by federal, state, municipal, provincial, local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.
 <br/>
 <br/>
 <strong>
  For Current Gilead Employees And Contractors
  <br/>
  <br/>
 </strong>
 Please apply via the Internal Career Opportunities portal in Workday.
</div>


Regulatory Affairs Manager

<div><b>Site Name:</b> Turkey - Istanbul<br>
<b>Posted Date:</b> Nov 4 2025<p><br>
At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&amp;D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people&rsquo;s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients&rsquo; needs and have the highest probability of success. We&rsquo;re uniting science, technology, and talent to get out of disease together. Find out more:</p><p>
Our approach to R&amp;D</p><p></p><p><b>
Regulatory Lead</b></p><p><br>
Are you ready to make a meaningful impact in regulatory affairs while advancing your career? In this role, you will play a key part in ensuring compliance with health authority regulations and supporting the delivery of regulatory submissions. You&rsquo;ll collaborate with cross-functional teams, contribute to process improvements, and help maintain the lifecycle of products. We value candidates who are detail-oriented, proactive, and passionate about driving results. Join us to grow your skills, work on impactful projects, and help us achieve our mission of uniting science, technology, and talent to get ahead of disease together.</p><p></p><p><b>
Responsibilites:</b></p><p>
This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:</p><div><ul><li><br>
Develop and implement regulatory strategies to ensure timely submissions and approvals.</li></ul></div><ul><li><br>
Preparation and completion of regulatory submissions and approvals of NCEs (new chemical entities) within the defined timelines</li><li>Execution of maintenance activities of the registered products including post-approval submissions (renewals, technical variations, new indication, label updates) and conduct effective cross-functional interactions to preserve business continuity</li><li>Execution and follow up regulatory processes for both locally manufactured and imported products.</li><li>Follow up CMC activities of locally manufactured products in collaboration with External Supply &amp; Quality teams</li><li>Follow up on the MoH correspondences.</li><li>Participation to brand teams and giving input for regulatory activities and action plans.</li><li>Execution of GMP related tasks including inspection submissions which require close follow up with internal and external stakeholders</li><li>Monitor changes in local and global regulations and assess their impact on product registrations.</li><li>Collaborate with cross-functional teams to ensure alignment and execution of regulatory plans.</li><li>Build and maintain strong relationships with health authorities and external stakeholders.</li><li>Identify risks and propose solutions to ensure business continuity and compliance.</li></ul><p></p><p><b><i>
Why you?</i></b></p><p><b>
Basic Qualifications</b></p><p>
We are seeking professionals with the following required skills and qualifications to help us achieve our goals:</p><div><ul><li><br>
Bachelor&rsquo;s degree in pharmacy, chemistry, or a related scientific field.</li><li>Minimum of 5 years of experience in regulatory affairs within the pharmaceutical industry.</li><li>Strong knowledge of local regulatory requirements and processes.</li><li>Proficiency in English (written and verbal).</li></ul></div><ul><li>Good knowledge of MS Office tools</li><li>Excellent organizational skills and attention to detail.</li><li>Ability to work collaboratively in a team environment and adapt to dynamic situations.</li></ul><p></p><p><b>
Preferred Qualifications</b></p><p></p><p>
If you have the following characteristics, it would be a plus:</p><div><ul><li><br>
Master&rsquo;s degree in regulatory affairs, pharmacy, or a related field.</li><li>Experience working in a matrixed, international environment.</li><li>Familiarity with regulatory systems and tools, such as Veeva Vault or similar platforms.</li><li>Knowledge of global regulatory requirements, including EU and US markets.</li><li>Strong interpersonal skills and ability to engage with senior stakeholders effectively.</li><li>Demonstrated ability to identify process improvement opportunities and implement solutions.</li></ul></div><p>
This role is hybrid, requiring two days per week in the office.<br>
<br>
If you&rsquo;re ready to take the next step in your career and contribute to impactful work, we encourage you to apply today!</p><p></p><p>
GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.</p><p></p><p><b>
Why GSK?</b><br>
<b>Uniting science, technology and talent to get ahead of disease together.</b></p><p></p><p>
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases &ndash; to impact health at scale.</p><p></p><p>
People and patients around the world count on the medicines and vaccines we make, so we&rsquo;re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.</p><p></p><p><b>
Contact information:</b><br>
You may apply for this position online by selecting the <b>Apply now</b> button.</p><p></p><p><b>
Important notice to Employment businesses/ Agencies</b></p><p>
GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.</p></div>

Regulatory Lead

Pfizer

<div><div>Job Summary</div><div>
Colleague fundamentally performs the ePALMS system &ldquo;Market Coordinator&rdquo; role in close collaboration with the Global Regulatory Sciences (GRS) Strategy functions at Pfizer Country Offices (PCOs) and is the central Regulatory point of contact for the PGS plants/Artwork Centers (AWC). Colleague operates from a subject matter expert (SME) centralized &ldquo;hub&rdquo; capacity and in some cases, may perform Regulatory Strategist roles &amp; responsibilities where specific tasks are delegated and in line with local and global<br>
SOPs/Work Instructions.</div><div><br>
As a seasoned &ldquo;Market Coordinator&rdquo; within ALIM these colleagues perform all activities of their more junior level peers including:</div><ul><li><div>
Initiation and &ldquo;build&rdquo; of Pfizer Artwork Requests (PARs) in collaboration with local markets, assuring all required information, specifications and/or supportive documentation is available for plants/AWCs to execute the production of product Labeling related packaging components.</div></li><li><div>
Negotiating Artwork Change Control logistics across multiple Pfizer departments (as well as multiple markets) to assure Regulatory timelines for Implementation are met and that product supply is not interrupted.</div></li><li><div>
Tracking Artwork, Key Performance Indicators (KPIs) (e.g. volume, timelines, and/or quality metrics) for assigned projects as well as broader regional or ALIM department deliverables when required. Accountability for Final Label Content rests with the PCOs or functions creating content.</div></li><li><div>
Research into root cause assessments for internal ALIM Quality Investigations or Area Quality Review Team (AQRT) meetings, identify opportunities for continuous improvements and prepare formal recommendations to ALIM leadership when appropriate.</div></li><li><div>
Retrieving documents and/or generating reports in response to queries from Regulatory Agencies (e.g. inspections) or Assistant General Counsel (e.g. product litigation cases related to Labeling in distribution).</div></li></ul><div></div><div>
However, incumbents may be tapped to represent ALIM on various cross-functional projects or sometimes lead ALIM continuous improvement teams. This could involve coordination of activities of other ALIM staff or contractors for the duration of the project.</div><div></div><div>
Job Responsibilities</div><div>
Liaises with markets and stakeholders to gather all necessary information to initiate and &ldquo;build&rdquo; PARs (according to local or regional requirements) to enable plant production of Labeling Artwork with minimal rework and to meet implementation requirements.</div><div><br>
Creates Editor&rsquo;s Copy (EC) for select markets depending on language(s) involved and specific &ldquo;custom&rdquo; services negotiated with markets in line with local SOPs.</div><div><br>
Liaises with GRO GLM/ILG functions, GRS PCOs and PGS AWCs, or demand management lines to coordinate any unique factors that need to be considered; documents agreement on Artwork timelines across stakeholders; escalates any issues/concerns within ALIM functional line and/or relevant leadership for adjudication as necessary.</div><div><br>
Performs ePALMS &ldquo;Market Coordinator&rdquo; role, according to agreed timelines and established procedures, by performing the following activities, which include:</div><ul><li><div>
Evaluates content of labeling updates and raises potential issues with GRS, PGS or relevant local markets as appropriate to minimize impact on schedules.</div></li><li><div>
Evaluates PGS sites impacted by labeling updates.</div></li><li><div>
Initiates PARs in collaboration with assigned market(s); ensures attributes (system metadata) are correct, and ensures all relevant Regulatory documents are included and routed for any shared packs, assures that agreed upon content is received in appropriate format and is either reflected in a combined EC or as a separate EC for each market according to regional agreements and relevant job aids.</div></li><li><div>
Uses Biopharmaceutical Packaging &amp; Artwork knowledge, in combination with Trade Dress Style Guides, Country Specific Requirements and/or other appropriate guidelines while collaborating with PGS AWCs to assure accurate packaging component ECs; escalates issues or concerns if/as needed</div></li><li><div>
Sends PARs to all relevant PGS sites; monitors and follows up on any aging PARs as needed.</div></li><li><div>
Upon receipt of final draft Artwork, reviews proofreading report and resolves any technical formatting questions or errors; assures necessary proofreading of final printed artwork against EC is completed using appropriate tools; escalates any issues, questions or errors within ALIM functional line or appropriate markets for adjudication as needed.</div></li><li><div>
Initiates, manages and tracks any necessary rework.</div></li><li><div>
Identifies appropriate Market Approvers for Packaging Artwork and electronically routes for approval using ePALMS lifecycle management; monitors progress and follows up as needed with appropriate PGS AWCs or GRS PCOs to assure agreed timelines are met and any Regulatory content issues that arise during the approval process are addressed.</div></li><li><div>
Tracks and communicates final approved labeling to list of relevant departments and stakeholders following final market review and signoff.</div></li><li><div>
Uploads any locally reconditioned or repackaged Artworks into ePALMS using &ldquo;dual role&rdquo; system capabilities to assure correct Artworks are available for next revision cycle.</div></li><li><div>
Leads teams in development and revisions of relevant SOPs for functional area.</div></li><li><div>
Works with minimal direct supervision; provides training and support to other team members or external vendors as required.</div></li><li><div>
Oversees work of other internal temporary personnel or external vendor staff as needed; tracks progress, monitors deliverables and intervenes if necessary; considers and adjudicates questions; assures volume, timeline, and/or quality performance metrics are met.</div></li><li><div>
Participates on cross-functional systems development and/or process improvement projects as assigned; contributes and/or advises teams in responding to new or revised legislation, regulations or guidelines for assigned market or region.</div></li></ul><div></div><div><br>
Qualifications / Skills</div><div>
Demonstrated previous experience with:</div><ul><li><div>
Document management tools used for storage, retrieval, lifecycle management and tracking, of Labeling related secondary packaging components (e.g. ePALMS, GLAMS, BLUE, GDMS, Agile, PfLEET or similar systems).</div></li></ul><ul><li><div>
Business Analytic tools used for tracking and reporting of product Labeling, Artwork or submissions (e.g. Business Objects, Spotfire, Tableau, Business Objects or similar reporting tools).</div></li></ul><ul><li><div>
Document review, copy editing or proofreading tools (e.g. Docu-Proof, TVT or similar tools).</div></li><li><div>
Some exposure to project management tools and processes (e.g. MS Project, Business Charters, Quad Charts, RACI, etc.)</div></li></ul><ul><li><div>
Knowledge of external labeling guidelines and regulations and internal labeling policies and procedures.</div></li></ul><ul><li><div>
Understand regulatory implications of product strategy with regards to the product label, assessment, and practical management of associated impacts.</div></li></ul><ul><li><div>
Working in an international role with broad exposure to different regulations and cultures.</div></li></ul><div></div><div>
Education &amp; Experience:</div><div></div><div><i>
Manager Level:</i> Bachelor&rsquo;s degree in an appropriate discipline, plus 6&ndash;8 years related work experience (at least 2-3 years of which are preferred to have been in a Labeling Artwork Change Control &amp; Implementation Management capacity or in roles such as Regulatory Strategy, Demand Management, Quality Operations or Supply Chain capacity which have frequent interactions with ALIM related specifically to Artwork Change Control and Implementation.</div><div><br>
NOTE: Substantial additional relevant experience may be considered in lieu of degree; or an advanced degree in an appropriate relevant discipline may be considered in lieu of some experience.</div><div></div><div>
Additional Qualifications/Attributes:</div><ul><li><div>
Must be familiar with Biopharmaceutical Regulatory environment and cGMPs associated with manufacturing, packaging &amp; distribution processes as well as a basic understanding of Artwork &amp; Labeling regulations and controls.</div></li></ul><ul><li><div>
Must be able to collaborate with cross-functional Pfizer teams, negotiate across globally distributed affiliates and manufacturing site personnel, and communicate across multiple levels of the organization in a clear professional manner.</div></li></ul><ul><li><div>
Solid PC business software skills including document authoring, spreadsheet, database management, and presentation applications are required.</div></li><li><div>
Strong written and verbal communication skills required</div></li><li><div>
Strong English language skills are required of non-native English-speaking colleague to enable global interactions.</div></li><li><div>
Must have multi-lingual skills.</div></li><li><div>
Must be able to work under pressure of tight timelines, apply sound judgment in ambiguous business situations, appropriately assess issues for potential impacts and ability to escalate if/as needed.</div></li><li><div>
Strong demonstrated project management and organizational skills.</div></li><li><div>
In-depth knowledge of PGS manufacturing and site processes/requirements.</div></li><li><div>
Must have capacity to solicit input in ambiguous business situations, resolve conflicting feedback and make appropriate business decisions.</div></li><li><div>
Attention to detail and ability to research and respond to audit/inspection queries.</div></li><li><div>
Ability to travel (Domestic and/or International) is required.</div></li></ul><div></div><div>
Organizational Relationships:</div><div>
This is a project management and troubleshooting role that Liases between local Pfizer Markets and relevant Manufacturing Plants or AWCs to assure timely implementation of artworks for labeling on packaging components according to local Regulatory Agency requirements.</div><div></div><div>
Colleague coordinates Artwork Change Control workflows for assigned products, markets and vendors. In this role colleague also negotiates Artwork Implementation requirements across clusters of markets with conflicting requirements and may sometimes work across regions.</div><div></div><div>
Colleagues liaise between key Packaging and Labeling Artwork stakeholders such as Global Regulatory Affairs (GRA), Global Labeling Management (GLM), International Labeling Group (ILG), Pfizer Global Supply (PGS) plants as well as relevant PGS Demand Management functions to coordinate. They often take the lead in negotiating Regulatory timelines for Artwork Implementation on Product Labeling and associated packaging components, taking into account conflicting drivers across markets and/or<br>
stakeholders to assure Regulatory requirements are met and product supply is not impacted.</div><div></div><div>
This role is an individual contributor and as such, has no direct reports or budget/cost center management responsibility.</div><div><br>
Work Location Assignment: Hybrid</div><div></div><div><div>
Purpose</div></div><div><div>
Breakthroughs that change patients' lives... At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives.</div></div><div></div><div><div><br>
School of Leaders</div><div>
We, as Pfizer Turkey, make a difference with our visionary and pioneering approaches ranging from our concept of raising leaders through rotations, providing international career opportunities to creating a flexible, enjoyable work environment. There are no limits to what we can accomplish to touch lives here!</div></div><div></div><div><div><br>
Flexibility</div><div>
We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let&rsquo;s start the conversation!</div></div><div></div><div><div><br>
Equal Employment Opportunity</div><div>
We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer is committed to celebrating this, in all its forms &ndash; allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.</div></div><div></div>
Regulatory Affairs</div><div></div>

Artwork Implementation Manager

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