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regulatory affairs, associate specialist Jobs in Istanbul

regulatory affairs, associate specialist

regulatory consultant

account specialist

accounting specialist

regulatory affairs associate specialist

Perrigo Company plc

<div>
 At Perrigo, we are driven by our mission to
 <em>
  <strong>
   Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All
  </strong>
 </em>
 . 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
 <strong>
  <em>
   The Best Self-Care for Everyone
  </em>
 </strong>
 , we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more.
 <strong>
  We Are Perrigo
 </strong>
 . 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.
 <br/>
 <br/>
 Join us on our One Perrigo journey as we evolve to win in self-care.
 <br/>
 <br/>
 <strong>
  Description Overview
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 <strong>
  Scope of the Role
  <br/>
  <br/>
 </strong>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Experience Required
  <br/>
  <br/>
 </strong>
 <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;
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Benefits
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 Find out more about
 <strong>
  Total Rewards
 </strong>
 at Perrigo.
 <br/>
 <br/>
 <strong>
  Hybrid Working Approach
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more
 <strong>
  here
  <br/>
  <br/>
 </strong>
 <strong>
  Applicants please note:
 </strong>
 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.
 <br/>
 <br/>
 <em>
  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
 </em>
</div>


Regulatory Affairs, Associate 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>

DEXIS

<div>
 <strong>
  Job Description
  <br/>
  <br/>
 </strong>
 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.
 <br/>
 <br/>
 <strong>
  Job Requirements
  <br/>
  <br/>
 </strong>
 <strong>
  Reports to Role
 </strong>
 : Head of RA Regions &amp; Registrations
 <br/>
 <br/>
 <strong>
  Location
 </strong>
 (HQ or Region, Country, Site):
 <br/>
 <br/>
 Istanbul, Turkey, EH TURKEY SA&Gbreve;LIK &Uuml;R&Uuml;NLER&Idot; VE H&Idot;ZMETLER&Idot; L&Idot;M&Idot;TED &Scedil;&Idot;RKET&Idot;. Fully remote
 <br/>
 <br/>
 <strong>
  <em>
   PURPOSE
  </em>
 </strong>
 <em>
  &ndash; in a few sentences, briefly describe the overall purpose of the role, i.e. why the role exists
  <br/>
  <br/>
 </em>
 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.
 <br/>
 <br/>
 The Regulatory Affairs Specialist is accountable for timely execution of regulatory strategies to support launch activities and maintain compliance status for international product registration.
 <br/>
 <br/>
 <strong>
  <em>
   ACCOUNTABILITIES
  </em>
 </strong>
 <em>
  &ndash; describe role accountabilities/responsibilities, i.e. what the role does. Should cover the following:
  <br/>
  <br/>
 </em>
 The Regulatory Affairs Specialist is accountable for compliance and delivery for all assigned countries and registrations in Regions.
 <br/>
 <br/>
 <strong>
  Regions &amp; Registrations
  <br/>
  <br/>
 </strong>
 <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 "regulatory submission packages" 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>
  <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>
  <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  <em>
   KNOWLEDGE, SKILLS &amp; EXPERIENCE
  </em>
 </strong>
 <em>
  &ndash;
 </em>
 <em>
  Functional/technical competencies specific to the role and required to perform the role
  <br/>
  <br/>
 </em>
 <strong>
  Critical Knowledge and Qualifications:
 </strong>
 <em>
  (what the role holder must know; including any required general or professional qualifications/education)
  <br/>
  <br/>
 </em>
 <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
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Critical Skills/technical know-how:
 </strong>
 <em>
  (what the role holder must be able to do)
  <br/>
  <br/>
 </em>
 <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.
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Critical Experience
  <br/>
  <br/>
 </strong>
 <ul>
  <li>
   Minimum 2 years' experience in regulatory affairs or associated field within medical device industry.
   <br/>
   <br/>
  </li>
 </ul>
 COMPETENCIES &ndash; Essential for the role
 <br/>
 <br/>
 <em>
  Determine max. 6 competencies, refer to List and Definition of Competencies
  <br/>
  <br/>
 </em>
 <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
   <br/>
   <br/>
  </li>
 </ul>
 <strong>
  Operating Company
  <br/>
  <br/>
 </strong>
 DEXIS
 <br/>
 <br/>
 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.
</div>


Regulatory Affairs Specialist

Medtronic

<div><p>At Medtronic you can begin a life-long career of exploration and innovation, while helping champion healthcare access and equity for all. You&rsquo;ll lead with purpose, breaking down barriers to innovation in a more connected, compassionate world.
</p><p></p><h1 class="jobSectionHeader"><b>A Day in the Life
</b></h1><p></p><p>Medtronic is committed to improving how healthcare addresses the needs of more people, in more ways, and in more places around the world. As one company, we can accelerate meaningful innovation and we will only succeed with the right people on our team.
</p><p></p><p>We are seeking an Associate Quality System Specialist to support the Center-Led organization with day-to-day activities. This role will provide support to stakeholders involved in Field Corrective Action (FCA) processes and will serve as the FCA conciliator. The position requires close collaboration with local quality representatives and commercial teams to ensure effective FCA execution in-country. Russian language proficiency is required.
</p><p></p><p><b>Responsibilities may include the following and other duties may be assigned:
</b></p><ul><li>Ensure full compliance with quality policies and procedures, supporting audits and operating within a regulated quality system.
</li><li>Coordinate and track all Field Corrective Action (FCA) activities, including translation, communication, and evidence consolidation (e.g., notification letters, reconciliation).
</li><li>Collaborate with cross-functional partners and QA SSC FCA specialist to drive timely execution and effectiveness checks of FCA tasks.
</li><li>Monitor accuracy and timeliness of recall data and reports, providing analytical support and updates to senior and corporate management.
</li><li>Maintain FCA documentation in the quality repository and follow up on missing or incomplete actions to ensure closure.
</li><li>Identify and implement process improvements to enhance compliance, efficiency, and collaboration across teams.
</li></ul><p></p><p><b>Required Knowledge and Experience:
</b></p><ul><li>Bachelor&rsquo;s degree in life sciences or a related field.
</li><li>Fluency in English and Russian.
</li><li>Ability to travel and work virtually with teams across the region.
</li><li>1+ years of experience in quality systems, regulatory affairs, or administrative roles.
</li><li>Previous experience supporting quality system audits is a plus.
</li><li>Strong technical writing and documentation review skills is valued.
</li><li>Excellent critical thinking and analytical abilities.
</li></ul><p></p><p>Preferred skills include the ability to make independent compliance decisions based on regulations, relevant information, alternatives, and risk, along with a solid understanding of Medical Device Regulations and the Food and Drugs Acts applicable to the role. Experience in writing and reviewing technical documentation is highly valued, and familiarity with tools such as SAP, Smartsheet, Map Agile, and Power BI is considered an advantage <i>.
</i></p><p></p><p><b>Physical Job Requirements
</b><br>
<br>
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
</p><p></p><h1 class="jobSectionHeader"><b>Benefits &amp; Compensation
</b></h1><p><b>Medtronic offers a competitive Salary and flexible Benefits Package
</b><br>
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.<br>
<br>
</p>This position is eligible for a short-term incentive called the Medtronic Incentive Plan (MIP).
<p></p><h1 class="jobSectionHeader"><b>About Medtronic
</b></h1><p>We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
<br>
Our Mission &mdash; to alleviate pain, restore health, and extend life &mdash; unites a global team of 95,000+ passionate people.
<br>
We are engineers at heart&mdash; putting ambitious ideas to work to generate real solutions for real people. From the R&amp;D lab, to the factory floor, to the conference room, every one of us experiments, creates, builds, improves and solves. We have the talent, diverse perspectives, and guts to engineer the extraordinary.</p></div><p></p>

Associate Quality System Specialist - Russian Speaker

Transmed Holding Limited

<div>Overview:
<div>
Transmed Turkiye is a full-service distributor company across 13 countries, managing distribution, sales, and marketing for 35 leading brands. We strongly believe in putting people first &ndash; our customers, our teams, our partners.</div><div></div><div><br>
We are seeking a <b>Regulatory Affairs Officer</b>.</div>
Responsibilities:<div></div><div><b><br>
JOB DESCRIPTION:</b></div><br>
<div></div><ul><li>
Conducting preliminary evaluations of imported and planned-to-be-imported products for compliance with local and international regulations,</li><li>
Managing the regulatory approval processes for food, food supplements, cosmetics, cleaning products, and animal-origin products,</li><li>
Following up on official correspondence with the Ministry of Agriculture and Forestry, Ministry of Health, and Ministry of Environment, Urbanization and Climate Change,</li><li>
Registering and archiving products in the relevant ministry systems (e.g., GGBS, HBS),</li><li>
Continuously monitoring regulatory updates and inform relevant departments in a timely manner,</li><li>
Managing the follow-up and renewal processes of supplier quality certificates,</li><li>
Collaborating with Demand Planning, Category, and Business Development teams during new product launches,</li><li>
Working in cooperation with consultancy firms during permit and approval processes.</li></ul>
Qualifications:<div></div><div><b><br>
*** This position does not offer a hybrid / remote option.</b></div><br>
<div></div><ul><li>
Bachelor&rsquo;s Degree in Food Engineering or in a related field,</li><li>
Minimum 2 years of experience in regulatory affairs for food, non-food, and cosmetic products,</li><li>
Preferably experienced in regulatory processes at consultancy or import companies,</li><li>
Advanced MS Office skills,</li><li>
Proficient in English,</li><li>
Proactive in following regulations, detail and result-oriented,</li><li>
Strong communication skills and a good team player,</li><li>
Completed military service for male candidates.</li></ul></div>

Regulatory Affairs Officer

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.
 <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>


Regulatory Affairs Manager

HUMAN KAPİTAL İNSAN KAYNAKLARI

<div><div>S&uuml;rekli / Tam Zamanlı</div>
<div></div><div><b>Referans Numarası :</b> 1981-2041-2025
</div><div>İşe Alınacak Kişi Sayısı : 1</div>
<div></div><div><p>T&uuml;rkiye - İstanbul (Asya)
</p></div>
<div></div><div><p><b>Pozisyon Seviyesi : </b>:Orta D&uuml;zey Y&ouml;netici</p>
</div><div></div><div><p><b>İş Alanı : </b>: Ruhsatlandırma</p>
</div><div><div><h4 class="jobSectionHeader"><b>Genel Nitelikler ve İş Tanımı :</b></h4>
</div><div><p>As <b>Human Kapital</b>, on behalf of our corporate client operating in the pharmaceutical industry, we are seeking an <b>International Regulatory Affairs Manager</b> with strong experience in overseas regulatory processes, solid knowledge of global regulations, and proven team management capabilities.</p><p></p><p><b>
Required Qualifications</b></p><ul><li>
Bachelor&rsquo;s degree in Pharmacy, Chemical Engineering, Chemistry, or a related field,</li><li>
Minimum 10 years of experience in the pharmaceutical industry,</li><li>
Prior experience in team management with demonstrated leadership skills,</li><li>
Preferably experienced in preparing overseas regulatory submission dossiers in <b>CTD format</b>,</li><li>
Strong knowledge of global regulations and international health authorities,</li><li>
Familiar with technology transfer processes and <b>R&amp;D (Product Development)</b> activities,</li><li>
Advanced level of English,</li><li>
Proficient in MS Office applications,</li><li>
Strong communication skills and a collaborative team player,</li><li>
For male candidates, completion of military service,</li></ul><p>
Able to reside in <b>Istanbul Ataşehir&ndash;Kadık&ouml;y</b> area or nearby districts.</p><p>
For Apply; https://humancapital.com.tr/ilan/143/international-regulatory-affairs-manager</p><p></p><p><b>
Duties and Responsibilities</b></p><ul><li>
Monitoring and implementing international regulatory requirements of relevant countries&rsquo; health authorities,</li><li>
Preparing overseas regulatory submission dossiers in compliance with country-specific requirements and managing the submission process,</li><li>
Following up all post-submission processes until product approval and ensuring internal coordination,</li><li>
Establishing effective communication with relevant health authorities,</li><li>
Preparing packaging mock-ups for products to be marketed abroad in accordance with the local language, and managing and tracking design approval processes,</li><li>
Notifying relevant country authorities of variations and changes made to licensed products,</li><li>
Tracking license renewal processes,</li><li>
Working in close cooperation with the Factory Quality Control unit,</li><li>
Contributing to R&amp;D processes,</li><li>
Following up variation approval processes,</li><li>
Managing and supervising the assigned team.</li></ul><p></p><p><b>
HUMAN KAPİTAL Human Resources and Consulting Services Industry and Trade Limited Company</b> is a private employment agency operating with the authorization of the Turkish Employment Agency dated <b>20.06.2025</b> and numbered <b>228</b>.<br>
In accordance with Law No. <b>4904</b> of the Turkish Employment Agency, no benefit of any kind may be obtained from job seekers.<br>
Charging job seekers any fee is strictly prohibited.</p>
</div></div><div><div><h4 class="jobSectionHeader"><b>Aday Kriterleri</b></h4>
</div><div><ul><li><b>İlan Tarihi : </b>15.12.2025</li>
<li><b>Eğitim Seviyesi: </b>Lisans Mezun, Y&uuml;ksek Lisans Mezun</li>
<li><b>Yaşadığı Şehir:</b> İstanbul (Asya),
</li><li><b>Tecr&uuml;be Yılı:</b> 10-0 Yıl</li>
<li><b>Yabancı dil ve seviyesi:</b> İngilizce - ( Seviye : İleri)<br>
</li><li><b>Askerlik Durumu:</b> Yapıldı, Muaf
</li><li><b>Firmanın Tercih Ettiği Sekt&ouml;rler :</b> İla&ccedil; &Uuml;retim ve Satışı</li></ul></div></div></div>

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