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administrative coordinator

regulatory affairs coordinator

Manpower Türkiye

<div>
 <p>
  We are looking for a
  <strong>
   "Regulatory Affairs Assistant to Specialist"
  </strong>
  on behalf of a client to whom we provide consultancy services, operating in the hearing aids and medical equipment industry.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Job Definition
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  &bull; Support the preparation, review, and submission of regulatory documentation in compliance with local and international requirements.
 </p>
 <p>
  &bull; Assist in maintaining regulatory files and product registration databases.
 </p>
 <p>
  &bull; Support audit and inspection preparation activities as needed.
 </p>
 <p>
  &bull; Collaborate effectively with different business teams to ensure smooth regulatory processes and timely submissions.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <strong>
   Qualifications
  </strong>
 </p>
 <p>
  <br/>
 </p>
 <p>
  &bull; Bachelor&rsquo;s degree in Pharmacy, Biomedical Engineering, Chemistry, Biology, or a related life sciences field.
 </p>
 <p>
  &bull; Up to 1 year of professional experience in Regulatory Affairs or related areas in medical device sector.
 </p>
 <p>
  &bull; Strong communication and coordination skills, with the ability to work effectively across departments.
 </p>
 <p>
  &bull; Excellent attention to detail and organizational skills.
 </p>
 <p>
  &bull; Fluency in English (both written and spoken) is required.
 </p>
 <p>
  &bull; Proficiency in MS Office applications.
 </p>
 <p>
  <br/>
 </p>
 <p>
  <br/>
 </p>
 <p>
  <em>
   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.
  </em>
 </p>
 <p>
 </p>
</div>


Regulatory Affairs Assistant to 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

Reckitt

<div>
 We are Reckitt
 <br/>
 <br/>
 Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose. Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
 <br/>
 <br/>
 Research &amp; Development
 <br/>
 <br/>
 In Research and Development, we're full of highly skilled talents that include Scientists, Engineers, Medical, Clinical and Regulatory professionals - all working to create a cleaner, healthier world. With nine Centres of Excellence, we continually seek out new opportunities by using science, our entrepreneurial flare and our fearless innovation to develop and enhance our existing portfolio, never compromising on quality or performance.
 <br/>
 <br/>
 We do the right thing, always, by ensuring we act with responsibility and integrity, by complying with regulatory legislation across the globe, whilst ensuring our products are safe for our consumers and are to the highest quality.
 <br/>
 <br/>
 The size of our organisation means you'll have the opportunity to learn and work in different functions within R&amp;D, giving you exposure to different disciplines, teams and environments. You will also have access to our Research and Development Academy, designed to develop our team and allow you to grow in our great organisation.
 <br/>
 <br/>
 <strong>
  About The Role
  <br/>
  <br/>
 </strong>
 As a Regulatory Associate, you&rsquo;ll be at the forefront of our innovation and compliance efforts. You&rsquo;ll jumpstart your career in a role that provides a blend of strategic thinking and hands-on experience within a dynamic, collaborative environment. If you have a passion for science and a drive to ensure the safety and efficacy of consumer products, your skills could be a perfect match for us. Together, we will work to navigate the exciting regulatory landscape, ensuring our diverse product range not only meets but exceeds the highest standards.
 <br/>
 <br/>
 Your responsibilities
 <br/>
 <br/>
 <ul>
  <li>
   Support the development and rollout of new products by navigating regulatory requirements and maintaining compliance.
  </li>
  <li>
   Engage with regulatory authorities, staying abreast of the changing landscape and expertly managing product compliance.
  </li>
  <li>
   Contribute to the team by formatting and compiling regulatory submission documents under guidance.
  </li>
  <li>
   Access and understand regulations and guidelines, applying them effectively to projects, as directed.
  </li>
  <li>
   Communicate and interact with cross-functional teams, playing a pivotal role in project meetings to understand objectives.
   <br/>
   <br/>
  </li>
 </ul>
 The experience we're looking for
 <br/>
 <br/>
 <ul>
  <li>
   0-3 years of experience within the regulatory field, ideally supported by a BSc or MSc in a scientific discipline such as chemistry and chemistry engineering.
  </li>
  <li>
   Ability to work under pressure while ensuring task execution and adherence to deadlines.
  </li>
  <li>
   Developing business acumen and commercial awareness, with a view to understanding product lifecycle management.
  </li>
  <li>
   Capacity for insight into consumer needs and expectations.
  </li>
  <li>
   Eagerness to collaborate, build partnerships, and continuously innovate.
   <br/>
   <br/>
  </li>
 </ul>
 The skills for success
 <br/>
 <br/>
 Task Execution Under Pressure, Business Acumen, Commercial Awareness, Objective Setting, Accountability, Consumer Insight, R&amp;D, Product Lifecycle Management, Intellectual Property, Business Partnership, Collaboration and partnership building, Adapt to changes in technological development plans, Ability to challenge the status quo and propose improvement, Innovation Processes.
 <br/>
 <br/>
 What we offer
 <br/>
 <br/>
 With inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way. We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
 <br/>
 <br/>
 Equality
 <br/>
 <br/>
 We recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you. All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.
</div>


Regulatory Associate (Hygiene) / Fixed Term Contract

Gilead Sciences

<div><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.</div><div><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.</div><div><br>
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.<br>
<br>
Job Description</div><div><br>
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.</div><div></div><div>
Knowledge &amp; Details:</div><ul><li><div>
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.</div></li><li><div>
Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.</div></li><li><div>
Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.</div></li><li><div>
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.</div></li><li><div>
Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.</div></li><li><div>
Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.</div></li><li><div>
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.</div></li><li><div>
Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.</div></li><li><div>
Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.</div></li><li><div>
Actively contribute to local and global initiatives that improve regulatory processes.</div></li></ul><div></div><div>
Professional Experience / Key Skills</div><ul><li><div>
Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.</div></li><li><div>
Degree in Pharmaceutical Sciences or equivalent discipline is preferred.</div></li></ul><ul><li><div>
Proven ability to prioritize, conduct, and manage time to meet project deadlines.</div></li><li><div>
Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.</div></li><li><div>
Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.</div></li><li><div>
Strong focus on achievement of goals and continuous improvement</div></li><li><div>
Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.</div></li><li><div>
Having excellence in multiple project management, good communication and interpersonal skills.</div></li><li><div>
Be an analytical thinker, problem solver, proactive, initiative taker, creative personality</div></li><li><div>
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.</div></li><li><div>
Fluency in spoken and written English.</div></li><li><div>
Good decision-making skills are important.</div></li><li><div>
Excellent verbal, written, organization skills and interpersonal communication skills required.</div></li></ul><div></div><div><br>
Equal Employment Opportunity (EEO)</div><div>
It is the policy of Gilead Sciences, Inc. and its subsidiaries and affiliates (collectively &quot;Gilead&quot; or the &quot;Company&quot;) 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.</div><div></div><div><br>
For Current Gilead Employees and Contractors:</div><div>
Please apply via the Internal Career Opportunities portal in Workday.</div></div>

Regulatory Affairs Manager

<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.
 <br/>
 <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.
 <br/>
 <br/>
 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.
 <br/>
 <br/>
 <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.
 <br/>
 <br/>
 <strong>
  Knowledge &amp; Details
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   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>
  <li>
   Stay up to date with local and global regulatory requirements (including ICH), internal policies and support the organization in adapting to legislative changes.
  </li>
  <li>
   Responsible from ensuring the updates to commercial product packaging and labelling in line with product licenses.
  </li>
  <li>
   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>
  <li>
   Ensure ongoing clinical trials comply with local legislation and oversee investigational product packaging and labelling approvals.
  </li>
  <li>
   Plan regulatory and clinical timelines and strategies under the guidance of the Regulatory Affairs Director.
  </li>
  <li>
   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.
  </li>
  <li>
   Build and maintain networks with regulatory stakeholders, including decision-makers and influencers.
  </li>
  <li>
   Develop and implement regulatory and clinical trial strategies, and manage negotiations with health authorities.
  </li>
  <li>
   Actively contribute to local and global initiatives that improve regulatory processes.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Professional Experience / Key Skills
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Solid experience in total in Regulatory Affairs &amp; Clinical Trials (if possible) related experience in the Pharmaceutical / Biotech Industry. An advanced degree is desirable.
  </li>
  <li>
   Degree in Pharmaceutical Sciences or equivalent discipline is preferred.
  </li>
  <li>
   Proven ability to prioritize, conduct, and manage time to meet project deadlines.
  </li>
  <li>
   Good influencing and negotiating skills. Must be capable of developing and implementing regulatory initiatives and managing negotiations with Regulatory Authorities.
  </li>
  <li>
   Demonstrates leadership skills with a sphere of influence externally, cross-functionally and within the RA and the affiliate.
  </li>
  <li>
   Strong focus on achievement of goals and continuous improvement
  </li>
  <li>
   Solution-oriented and innovative; can identify creative options for resolving issues that respond to multiple stakeholder interests and needs.
  </li>
  <li>
   Having excellence in multiple project management, good communication and interpersonal skills.
  </li>
  <li>
   Be an analytical thinker, problem solver, proactive, initiative taker, creative personality
  </li>
  <li>
   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.
  </li>
  <li>
   Fluency in spoken and written English.
  </li>
  <li>
   Good decision-making skills are important.
  </li>
  <li>
   Excellent verbal, written, organization skills and interpersonal communication skills required.
   <br/>
   <br/>
  </li>
 </ul>
 Equal Employment Opportunity (EEO)
 <br/>
 <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>


<div><p>Job Description</p><p></p><p>
The Medical Affairs Manager holds primary responsibility within the country for the development and execution of the Medical Affairs strategic plans and, is expected to spend at least 50% of their time in external engagements. Key responsibilities include cross-functional strategy collaboration and execution, building trust with the medical/scientific community, facilitating peer-to-peer medical and scientific exchange, and providing asset issue resolution support.</p><p></p><p><b>
Job Description</b></p><ul><li><p>
Translates Global Medical Goals and Strategies into tactics and solutions that support optimal scientific exchange aimed at helping improve patient outcomes and enhancing access in collaboration with colleagues,</p></li><li><p>
Facilitates the delivery of data generation activities (phases I-IV), including the identification of suitable research projects, research centers, investigators, and innovative methods to generate data,</p></li><li><p>
Provides non-promotional, balanced, and reliable scientific information following company standards and local regulations,</p></li><li><p>
Communicates scientific and business needs appropriately and effectively across internal and external stakeholders, Leads country advisory boards and expert input forums,</p></li><li><p>
Provides access support as needed (e.g., health technology assessment, pre-license patient access, reimbursement dossier).</p></li><li><p>
Evaluate and interpret medical literature, abstract and writing medical information in various formats</p></li><li><p>
Ability to review/understand complex scientific and medical data from clinical trials (and summarize content in both written and verbal forms)</p></li></ul><p></p><p><b>
Qualifications</b></p><ul><li><p>
Medical Degree or higher (e.g., PhD),</p></li><li><p>
A minimum of 2-3 years of medical affairs experience in relevant disease area</p></li><li><p>
Experience with local pharmaceutical industry guidelines, regulatory/reimbursement framework, and clinical research guidelines,</p></li><li><p>
Excellent command of both written and spoken English,</p></li><li><p>
Ability to effectively collaborate across functions in a matrix environment.</p></li></ul><p></p><p><b>
Required Skills:
</b></p>Advisory Board Development, Clinical Trials, Data Analysis, Medical Literature Review, Pharmaceutical Guidelines, Professional Presentation, Regulatory Frameworks, Scientific Communications, Stakeholder Engagement, Strategic Thinking<p></p><p><b>
Preferred Skills:
</b></p><p></p><p>Current Employees apply HERE</p><p></p><p>
Current Contingent Workers apply HERE</p><p></p><p><b>
Search Firm Representatives Please Read Carefully</b><br>
Merck &amp; Co., Inc., Rahway, NJ, USA, also known as Merck Sharp &amp; Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.</p><p></p><p><b>
Employee Status:
</b></p>Regular<p></p><p><b>
Relocation:</b></p><p></p><p><b>
VISA Sponsorship:</b></p><p></p><p><b>
Travel Requirements:</b></p><p></p><p><b>
Flexible Work Arrangements:</b></p>
Hybrid<p></p><p><b>
Shift:</b></p><p></p><p><b>
Valid Driving License:</b></p><p></p><p><b>
Hazardous Material(s):</b></p><p></p><p><b>
Job Posting End Date:</b></p>
11/28/2025<ul><li><b>A job posting is effective until 11:59:59PM on the day </b><b>BEFORE</b><b> the listed job posting end date. Please ensure you apply to a job posting no later than the day </b><b>BEFORE</b><b> the job posting end date.<br>
</b></li></ul><br>
<p><b>Requisition ID:</b>R374126</p></div>

Medical Affairs Manager, Cardiovascular

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