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regulatory affairs associate specialist

Perrigo France

<div>
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 <br/>
 <br/>
 Regulatory Affairs, Associate Specialist
 <br/>
 <br/>
 Location:
 <br/>
 <br/>
 Istanbul, TR, 34732
 <br/>
 <br/>
 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
  <br/>
  <br/>
 </em>
 Apply now &raquo;
 <br/>
 <br/>
 <strong>
  Find Similar Jobs
  <br/>
  <br/>
 </strong>
 Scientific Affairs_UK, Scientific Affairs_GR, Scientific Affairs_FR, Scientific Affairs_DE, Scientific Affairs
</div>


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>


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

Pfizer

<div><div><div>ROLE SUMMARY:</div></div><div></div><div><div>
Bridging science, strategy and medical innovation, the medical organization will have a lasting impact on patients across diverse European healthcare landscapes.</div></div><div><div>
The Specialty Care Category Director (SCCD) will lead a team of medical affairs scientists dedicated to Pfizer&rsquo;s assets (Inflamation &amp; Immunology, Hospital and Rare Diseases) in T&uuml;rkiye reporting directly to Country Medical Senior Director. This team will ensure the safe and effective use of Pfizer medicines and vaccines.</div></div><div><div>
As part of the Specialty Care Category LT, the SCCD will drive scientific and operational excellence for all Specialty Care Category (SCC) medical processes and will manage Medical Affairs Scientists.</div></div><div></div><div><div>
ROLE RESPONSIBILITIES</div></div><div><ul><li><div>
Accountable for informing and co-developing the SCC medical operating plan and fully accountable for execution while embracing new tools and frameworks for medical excellence and operational efficiency.</div></li><li><div>
Drives a customer and patient centric medical organization that leverages strong scientific and medical expertise to build strong partnerships with HCPs, regulators, and external stakeholders, while providing strategic thought partnership for commercial marketing, regulatory, compliance and access initiatives.</div></li><li><div>
Represents the SCC to external bodies for SCC related issues;</div></li><li><div>
Represents SCC through relationships with medical associations, societies, academic medical centers and industry associations.</div></li></ul></div><div><ul><li><div>
Plans and executes the respective KOL strategy for Turkey on highly ethical and medical professionalism grounds and brings their input into the medical strategies and plans;</div></li><li><div>
Communicates the value of the MA function to internal stakeholders (championing cross functional working, and working with the Global and Emerging Market teams and Country Medical Director);</div></li><li><div>
Along with Category and MQG teams, designs, implements and evaluates systems and processes to ensure full compliance with legal and regulatory requirements.</div></li><li><div>
A caring, compassionate and authentic leader who upholds the highest standards of ethics, probity, integrity and compliance with regulatory, financial and legal requirements and fosters a high-performing medical team culture, supporting growth and talent development.</div></li><li><div>
Leads, manages and coaches in-country Medical Affairs Scientists who will generate, analyse, exchange and act on insights that support the safe and effective development and utilization of Pfizer medicines and vaccines to improve patient outcomes.</div></li><li><div>
Communicates the value of the MA function to external stakeholders, aligning with customer needs, enhancing reputation and bringing medical insights into the organisation.</div></li></ul><div></div><div>
QUALIFICATIONS</div><div><ul><li><div>
A Pharmacy or Medical degree coupled with strong pharmaceutical experience and knowledge. A medical degree (MD) and/or PhD is highly desirable.*</div></li></ul></div><div><ul><li><div>
Minimum of 5 years of experience in medical affairs or transferrable knowledge from related roles is of preference. (Therapeutic area experience is preferred)</div></li></ul></div><div><ul><li><div>
Experience in leading teams through transformation is of preference.</div></li></ul></div><div><ul><li><div>
Ability to lead in a matrixed, cross-functional environment.</div></li></ul></div><div><ul><li><div>
Strong understanding of Turkish healthcare system, regulatory landscapes, and medical governance.</div></li></ul></div><div><ul><li><div>
A full, detailed understanding of regulatory requirements and compliance in the pharmaceutical industry</div></li></ul></div><div><ul><li><div>
Excellent communication, interpersonal and leadership skills.</div></li></ul><div></div><div>
CORE COMPETENCIES</div><div><ul><li><div>
Holds people accountable;</div></li></ul></div><div><ul><li><div>
Strategic and innovative thinking;</div></li></ul></div><div><ul><li><div>
Commits to &ldquo;One Pfizer&rdquo;;</div></li></ul></div><div><ul><li><div>
Anticipates customer and market needs.</div></li></ul><div></div><div>
TECHNICAL/FUNCTIONAL COMPETENCIES</div><div><ul><li><div>
Fluency in business English;</div></li></ul></div><div><ul><li><div>
Ability to analyze, define and convey complex concepts and strategies and to communicate these to demanding external and internal stakeholders;</div></li></ul></div><div><ul><li><div>
Excellent strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges together with the ability to balance short-term needs and long-term vision.</div></li></ul></div><div></div><div><div>
This is a GJL 100 role</div><ul><li>(Exceptional situation for the latter educational requirement does not apply to those colleagues who are Pharmacists only and who already hold a Medical Affairs position internally)</li></ul></div></div></div></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>
Medical</div><div></div>

Specialty Care Category Medical Director, Türkiye

<div><div><div><div>ROLE SUMMARY:</div></div><div></div><div><div>
Bridging science, strategy and medical innovation, the medical organization will have a lasting impact on patients across diverse European healthcare landscapes.</div></div><div><div>
The Primary Care Category Director (PCD) will lead a team of medical affairs scientists dedicated to Pfizer&rsquo;s Vaccines and Internal Medicine assets in T&uuml;rkiye reporting directly to Country Medical Senior Director. This team will ensure the safe and effective use of Pfizer medicines and vaccines.</div></div><div><div>
As part of the Primary Care Category LT, the Medical Category Director will drive scientific and operational excellence for all Primary Care Category medical processes and will manage Medical Affairs Scientists.</div></div><div></div><div><div><br>
ROLE RESPONSIBILITIES</div></div><div><ul><li><div>
Accountable for informing and co-developing the Primary Care Category (PCC) medical operating plan and fully accountable for execution while embracing new tools and frameworks for medical excellence and operational efficiency.</div></li></ul></div><div><ul><li><div>
Drives a customer and patient centric medical organization that leverages strong scientific and medical expertise to build strong partnerships with HCPs, regulators, and external stakeholders, while providing strategic thought partnership for commercial marketing, regulatory, compliance and access initiatives.</div></li></ul></div><div><ul><li><div>
Represents the PCC to external bodies for Vaccine related issues;</div></li></ul></div><div><ul><li><div>
Represents PCC through relationships with medical associations, societies, academic medical centers and industry associations;</div></li></ul></div><div><ul><li><div>
Plans and executes the respective KOL strategy for Turkey on highly ethical and medical professionalism grounds and brings their input into the medical strategies and plans;</div></li></ul></div><div><ul><li><div>
Communicates the value of the MA function to internal stakeholders (championing cross functional working, and working with the Global and Emerging Market teams and Country Medical Director);</div></li></ul></div><div><ul><li><div>
Along with Category and MQG teams, designs, implements and evaluates systems and processes to ensure full compliance with legal and regulatory requirements.</div></li></ul></div><div><ul><li><div>
A caring, compassionate and authentic leader who upholds the highest standards of ethics, probity, integrity and compliance with regulatory, financial and legal requirements and fosters a high-performing medical team culture, supporting growth and talent development.</div></li></ul></div><div><ul><li><div>
Leads, manages and coaches in-country Medical Affairs Scientists who will generate, analyse, exchange and act on insights that support the safe and effective development and utilization of Pfizer medicines and vaccines to improve patient outcomes.</div></li></ul></div><div><ul><li><div>
Communicates the value of the MA function to external stakeholders, aligning with customer needs, enhancing reputation and bringing medical insights into the organisation.</div></li></ul></div></div><div></div><div><div><div>
QUALIFICATIONS</div></div><div><ul><li><div>
A Pharmacy with PhD or Medical degree coupled with strong pharmaceutical experience and knowledge. A medical degree (MD) and/or PhD is highly desirable.*</div></li></ul></div><div><ul><li><div>
Minimum of 5 years of experience in medical affairs or transferrable knowledge from related roles is of preference. (Vaccines exp. is preferred)</div></li></ul></div><div><ul><li><div>
Experience in leading teams through transformation is of preference.</div></li></ul></div><div><ul><li><div>
Ability to lead in a matrixed, cross-functional environment.</div></li></ul></div><div><ul><li><div>
Strong understanding of Turkish healthcare system, regulatory landscapes, and medical governance.</div></li></ul></div><div><ul><li><div>
A full, detailed understanding of regulatory requirements and compliance in the pharmaceutical industry</div></li></ul></div><div><ul><li><div>
Excellent communication, interpersonal and leadership skills.</div></li></ul></div><div></div><div><div>
CORE COMPETENCIES</div></div><div><ul><li><div>
Holds people accountable;</div></li></ul></div><div><ul><li><div>
Strategic and innovative thinking;</div></li></ul></div><div><ul><li><div>
Commits to &ldquo;One Pfizer&rdquo;;</div></li></ul></div><div><ul><li><div>
Anticipates customer and market needs.</div></li></ul></div><div></div><div><div>
TECHNICAL/FUNCTIONAL COMPETENCIES</div></div><div><ul><li><div>
Fluency in business English;</div></li></ul></div><div><ul><li><div>
Ability to analyze, define and convey complex concepts and strategies and to communicate these to demanding external and internal stakeholders;</div></li></ul></div><div><ul><li><div>
Excellent strategic skills including creativity and effectiveness in identifying and addressing major strategic challenges together with the ability to balance short-term needs and long-term vision.</div></li></ul></div><div><div>
This is a GJL 100 role</div></div><div><ul><li>(Exceptional situation for the latter educational requirement does not apply to those colleagues who are Pharmacists only and who already hold a Medical Affairs position internally)</li></ul></div></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>
Medical</div><div></div>

Primary Care Category Medical Director, Türkiye

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>

INTERNATIONAL REGULATORY AFFAIRS MANAGER

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