senior regulatory affairs specialist

UTOPIA INDUSTRIES PVT LTD

<p><b>Regulatory Compliance Officer/ Specialist &ndash; Dietary Supplements</b></p><p><b>Education: </b>Bachelor&rsquo;s/Master&rsquo;s degree in Pharmacy, Food Science, Nutrition, Biotechnology, or Regulatory Affairs.</p><p><b>Experience: </b>Minimum 3&ndash;5 years in product regulatory compliance, preferably in dietary supplements, cosmetics, or nutraceuticals.</p><p>KeyResponsibilities:</p><ul><li>Ensure all dietary supplements comply with U.S. FDA Dietary Supplement regulations under the FD&amp;C Act and 21 CFR 111 (cGMP).</li><li>Review and verify supplier documentation, including Certificates of Analysis (COA), GMP certificates, NDI notifications, product dossiers, permitted ingredients, prohibited or restricted ingredients and formulation specifications.</li><li>Ensure scientific substantiation of ingredient functions and claims.</li><li>Review all product labels, claims and Amazon listings for compliance with FDA labeling guidelines (identity statement, net quantity, Supplement Facts, ingredient declaration, warnings).</li><li>Communicate with suppliers to ensure documentation completeness, GMP certification, facility registration, and FDA establishment listing and product conformity.</li><li>Evaluate supplier test data for microbial, heavy metals, and purity compliance.</li><li>Ensure all required premarket notifications (e.g., NDIN, if applicable) are filed or confirmed by the supplier, manage product listing on Amazon and FDA notification (via SPL) if needed.</li><li>Oversee post-market vigilance, including consumer complaint tracking, recall coordination, and adverse event reporting.</li><li>Work closely with QA/QC, Procurement, and Marketing teams to integrate regulatory compliance early in product selection.</li><li>Support packaging and labeling approval cycles before production.</li></ul><p>Job Type: Full-time</p><p>Work Location: In person</p>

Regulatory Affairs Specialist

Amgen

Associate Regulatory Affairs - based in Dubai <p>Join to apply for the <b>Associate Regulatory Affairs - based in Dubai</b> role at <b>Amgen</b>.</p><p>You've worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? At Amgen, our shared mission-to serve patients-drives all that we do. It is key to our becoming one of the world's leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.</p> What You Will Do <p>Let's do this. Let's change the world. In this vital role, you will manage country specific regulatory affairs for Amgen's molecules, coordinate and implement regulatory submissions, ensure compliance with corporate and local requirements and lead documentation for local submissions under Senior Manager's guidance:</p><ul><li>Ensures regulatory submissions are made on time and meet Amgen's corporate and local regulatory requirements</li><li>Reviews promotional and non promotional materials.</li><li>Exchanges regulatory information and intelligence with other regulatory colleagues and cross functional teams on an ongoing basis and provides advice on local regulatory considerations/regulations in a timely manner.</li><li>Partners with International Regulatory Leads (IRLs) and Global Regulatory Leads (GRLs) to support the regulatory development, registration, and lifecycle management of all Amgen molecules.</li><li>Partners with peers to ensure consistency on procedures.</li></ul> What We Expect Of You <p>We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a teammate with these qualifications.</p> Basic Qualifications <ul><li>Bachelor's degree in Pharmaceutical Science</li><li>Working with policies, procedures and SOPs.</li><li>Comprehensive understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Knowledge of the Gulf legislation and regulations.</li><li>Understanding of regulatory activities and how they impact other projects and/or processes.</li><li>Understanding of drug development.</li><li>Demonstrate ability to work in teams.</li><li>Ability to understand and communicate scientific/clinical information.</li></ul> Preferred Qualifications <ul><li>Regulatory experience of the Gulf Markets.</li><li>Knowledge of regional countries legislation and regulations relating to medicinal products in the Gulf Markets.</li><li>Experience interacting with regulatory agency in the Gulf markets.</li></ul> What You Can Expect Of Us <p>As we work to develop treatments that take care of others, we also work to care for our teammates' professional and personal growth and well being. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards.</p><p>Apply now at </p><p>Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.</p>

Associate Regulatory Affairs - based in Dubai

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>


<div><div>Job Description Summary</div>
This position independently supports projects to bring new and modified medical devices to market and ensure ongoing compliance. This position participates on cross-functional teams, leads the development of global regulatory strategies, authors regulatory submissions, interacts with regulatory agencies/notified<br>
bodies, reviews design control documents and product labeling, and evaluates proposed device changes.<br>
This position interprets and communicates regulatory issues to ensure the business is aware of opportunities, risks, and concerns; and provides recommendations to minimize risk.<div></div><div>
Job Description</div><div>
P3-14314 - (TCI Role - JG 3C)</div><div>
Job Responsibilities:</div><ul><li>
Represents Regulatory Affairs on product development teams to support change control to ensure US, EU, and other global regulatory requirements are met</li><li>
Evaluates medical device regulations and leads development of global regulatory strategies to bring products to market</li><li>
Reviews and approves design control documentation and product labeling in consideration of US, EU, and other global regulatory requirements</li><li>
Authors FDA submissions, EU technical files, and other regulatory documents for submission to regulatory bodies for product review and approval</li><li>
Point of contact for FDA, EU notified bodies, and other regulatory agencies on submissions and other issues</li><li>
Independently reviews product changes to ensure regulatory compliance, including assessment of impact to US and CE Mark and prepares resulting notifications</li><li>
Communicates changes to global regions and supports preparation of global notifications as needed</li><li>
Understands fundamental global regulatory requirements and different regulatory pathways</li><li>
Stays informed of new regulations and changes to existing regulations and communicates to project teams</li><li>
Maintains regulatory databases and systems</li><li>
Supports regulatory body audits, CAPAS, and other compliance activities</li><li>
Reviews advertising and promotional material</li><li>
Participates and leads training related to areas of expertise</li><li>
Mentor other regulatory colleagues</li></ul><div></div><div>
Education and Experience:</div><ul><li>
Bachelor's degree or higher, preferably in a scientific discipline</li><li>
Master's degree in Regulatory Affairs preferred</li><li>
Regulatory Affairs Professional Society (RAPS) certification preferred</li><li>
7- 12 years&rsquo; Regulatory Affairs experience in the medical device industry</li><li>
Experience working with FDA, EU notified bodies, and other regulatory agencies</li><li>
Experience with US 510(k), CE mark (EU MDD/MDR), and other international requirements and submissions</li><li>
Proven experience owning and managing the end-to-end process of authoring, submitting and obtaining regulatory approvals/clearances (510(k)s), including addressing and responding to deficiencies from regulatory agencies</li><li>
Experience with product development processes and design controls</li></ul><div></div><div>
 Knowledge and Skills:</div><ul><li>
Excellent written and verbal communication skills</li><li>
Excellent problem solving and analytical skills</li><li>
Detail-oriented, with a focus on accuracy and completeness</li><li>
Excellent organization skills: able to manage multiple tasks and meet timeline commitments</li><li>
Ability to work in a team-oriented, fast-paced environment</li><li>
Demonstrated ability to analyze, interpret, review, and summarize scientific, technical, and regulatory information</li><li>
Comprehensive understanding of global medical device regulations, with in-depth knowledge of US and EU requirements</li><li>
Knowledge of product development and medical device quality system regulations</li><li>
Ability to mentor and teach other regulatory associates</li><li>
Proficient in use of Microsoft Office tools (including Word, Excel, PowerPoint)</li></ul><div></div><div>
Required Skills</div><div>
Optional Skills</div><div></div><div>
.</div><div>
Primary Work Location</div>
IND Bengaluru - Technology Campus<div></div><div>
Additional Locations</div><div></div><div>
Work Shift</div></div>

Lead Regulatory Affairs Specialist

HUMAN KAPİTAL İNSAN KAYNAKLARI

<div><div>S&uuml;rekli / Tam Zamanlı</div>
<div></div><div><b>Referans Numarası :</b> 1981-2032-2025
</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>:Şef / Y&ouml;netici Adayı</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><b>Position Summary</b></p><p>
This role is responsible for ensuring that the company&rsquo;s regulatory activities in international markets (EU, UK, GCC/KSA, CIS, etc.) are executed completely, compliantly, and on time. End-to-end management of documentation processes, correspondence with global authorities, strategic regulatory planning, and coordination within a multi-stakeholder structure are the core responsibilities of the position.</p><p>
Due to the diversity of the product portfolio and target markets, the role offers strong career development opportunities in strategic decision-making, gaining mastery of international regulations, and continuous professional learning.</p><p></p><p><b>
Qualifications</b></p><p><b>
Education: </b>Bachelor&rsquo;s / Master&rsquo;s degree in Pharmacy, Chemistry, Biology, Molecular Biology, Chemical Engineering, or related fields.</p><p><b>
Experience: </b>3&ndash;6 years of managerial experience in international regulatory affairs within the pharmaceutical industry.</p><p><b>
Languages: </b>Advanced English; German is an asset.</p><p></p><p><b>
Technical Skills</b></p><ul><li>
Advanced command of CTD &ndash; eCTD structure</li><li>
Knowledge of international regulatory requirements (EU, UK, GCC, CIS, etc.)</li><li>
Experience in dossier preparation and assessment</li><li>
Knowledge of pharmaceutical manufacturing technologies</li><li>
Project management competencies</li><li>
Strong scientific and technical writing skills</li></ul><p></p><p><b>
Personal Competencies</b></p><ul><li>
Strong team collaboration</li><li>
Excellent communication and negotiation skills</li><li>
Time management, analytical thinking, and problem-solving ability</li><li>
Stress management and ability to take initiative</li><li>
Coordination skills in multi-stakeholder environments</li><li>
High discipline in documentation management</li></ul><p><b>
Location:</b> Ataşehir Region</p><p>
For Apply; https://humancapital.com.tr/ilan/135/senior-international-regulatory-affairs-executive</p><p></p><p><b>
Responsibilities</b></p><ul><li>
Developing regulatory strategies aligned with target markets</li><li>
Preparing, updating, and tracking CTD (Modules 1&ndash;5) dossiers in line with country regulations</li><li>
Managing all formal correspondence with EMA, MHRA, SFDA, and other authorities</li><li>
Providing scientific and timely responses to authority questions (deficiency, clock stop, validation queries)</li><li>
Managing regulatory timelines in alignment with launch plans</li><li>
Executing variation, renewal, and lifecycle management processes</li><li>
Preparing and updating SmPC, PIL, artwork, and labeling documents</li><li>
Coordinating with R&amp;D, Manufacturing, Quality, Analytical, and Supply Chain teams</li><li>
Managing processes with external stakeholders (consultants, distributors, regulatory agencies)</li><li>
Monitoring international regulatory changes and communicating updates to relevant teams</li></ul><p></p><p>
HUMAN KAPİTAL Human Resources and Consulting Services Industry &amp; Trade Ltd. is a private employment agency operating with the permission certificate No. 228 dated 20.06.2025 issued by the Turkish Employment Agency (İŞKUR). In accordance with Law No. 4904, no benefits of any kind may be obtained from job seekers, and charging job seekers a 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>12.12.2025</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> 5-0 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>

Senior Domestic & International Regulatory Affairs

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>

Search 10000+ Senior regulatory affairs specialist jobs near you this December. New roles added regularly across leading industries. Apply today.

10000 senior regulatory affairs specialist jobs NEAR_ME

Regulatory Affairs Specialist

Associate Regulatory Affairs - based in Dubai

Regulatory Affairs Specialist

Lead Regulatory Affairs Specialist

Senior Domestic & International Regulatory Affairs

Regulatory Affairs, Associate Specialist

Regulatory Affairs, Associate Specialist