regulatory affairs specialist

AL Sharq Modern Trading

Regulatory Affairs Specialist &ndash; Job Description (Qatar)Position SummaryThe Regulatory Affairs Specialist is responsible for ensuring that all company products, operations, and activities comply with the regulatory requirements of the State of Qatar. This includes managing product registrations, approvals, certifications, renewals, and coordinating with government authorities such as the Ministry of Public Health (MOPH), Qatar Ministry of Commerce &amp; Industry (MOCI), Qatar Customs, Civil Defense, Baladiya (Municipality), and other relevant bodies.Key ResponsibilitiesRegulatory Compliance &amp; Documentation<ul><li>Prepare, review, and submit regulatory documents required for product approvals, import permits, and company licensing.</li><li>Register and renew products with MOPH (Pharmaceuticals, Medical Devices, Food, Cosmetics), Municipality, and other regulatory bodies.</li><li>Ensure product labels, safety data sheets, and brochures comply with Qatar&rsquo;s regulatory standards.</li><li>Maintain updated knowledge of Qatar laws, regulations, circulars, and procedures.</li></ul>Coordination with Authorities<ul><li>Liaise with government authorities including MOPH, MOCI, Baladiya, Karama, SASO/GSO (if GCC-related), and Qatar Customs.</li><li>Monitor and track the progress of submissions and approvals; follow up with authorities when necessary.</li></ul>Licensing &amp; Approvals<ul><li>Manage the renewal and compliance of company CR, trade licenses, regulatory approvals, and facility permits.</li><li>Ensure timely renewal of registration certificates, conformity certificates, and import/export authorizations.</li></ul>Internal Support<ul><li>Work closely with departments such as Quality, Logistics, Procurement, and Sales to ensure regulatory requirements are met before importing or selling products.</li><li>Guide the team on regulatory changes and new compliance requirements.</li><li>Support internal and external audits related to regulatory matters.</li></ul>Record Management<ul><li>Maintain systematic and accurate documentation of all regulatory files.</li><li>Create and update regulatory databases, trackers, and reports.</li></ul>Qualifications &amp; Requirements<ul><li>Bachelor&rsquo;s degree in Pharmacy, Biomedical Science, Chemistry, Engineering, or a related field.</li><li>Minimum 2&ndash;5 years of experience in Regulatory Affairs, preferably within Qatar.</li><li>Strong knowledge of Qatar MOPH, Baladiya, MOCI, and Customs regulations.</li><li>Excellent communication and report-writing skills.</li><li>High accuracy, attention to detail, and strong organization skills.</li><li>Proficient in Microsoft Office; experience with e-submission portals is a plus.</li><li>Ability to manage multiple tasks with tight deadlines.</li></ul>Preferred Skills<ul><li>Experience in medical devices, pharmaceuticals, cosmetics, food, or chemical product registration.</li><li>Strong coordination skills and ability to work independently.</li></ul>Work Environment<ul><li>Office-based role with visits to MOPH, Municipality, Customs, Civil Defense, and other regulatory entities when required.</li><li>Regular interaction with internal departments and external authorities.</li></ul>Job Types: Full-time, PermanentPay: From QAR3,000.00 per month

Regulatory Affairs Specialist

UTOPIA INDUSTRIES PVT LTD

Regulatory Compliance Officer/ Specialist &ndash; Dietary SupplementsEducation: Bachelor&rsquo;s/Master&rsquo;s degree in Pharmacy, Food Science, Nutrition, Biotechnology, or Regulatory Affairs.Experience: Minimum 3&ndash;5 years in product regulatory compliance, preferably in dietary supplements, cosmetics, or nutraceuticals.KeyResponsibilities:<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>Job Type: Full-timeWork Location: In person

HRCONSOL

HRCONSOL is Hiring | Regulatory Affairs Specialist (Cosmetics, Skincare &amp; Nutraceuticals)HRCONSOL is hiring for a leading E-Commerce company in Karachi and we are looking for a highly skilled Regulatory Affairs Specialist with strong expertise in Cosmetics, Skincare, and Nutraceuticals.Location: Karachi (On-site) Salary: PKR 100,000 &ndash; 300,000 + Benefits Apply at: jobs@hrconsol.comJob ResponsibilitiesCosmetics &amp; Skincare Regulatory Compliance<ul><li>Evaluate suppliers to ensure compliance with U.S. FDA MoCRA, ISO 22716 (Cosmetic GMP), and ingredient safety standards.</li><li>Review &amp; approve supplier documentation including COA, SDS, CPSR, GMP certificates, test reports, ingredient lists, MoCRA filings, and marketing claims.</li><li>Maintain complete compliance documentation for each product (formulation data, safety assessments, labeling proofs, MoCRA listings).</li><li>Validate Responsible Person (RP) arrangements and import compliance as per FDA rules.</li><li>Verify supplier labeling and artwork according to MoCRA &amp; FTC advertising guidelines.</li><li>Coordinate with suppliers for adverse event monitoring, recall readiness, risk communication protocols, and reporting duties under MoCRA.</li><li>Liaise with FDA, Regulatory Consultants, and RPs for submissions &amp; resolving compliance issues.</li><li>Track and interpret updates in MoCRA, FDA guidance, and global cosmetic regulations; advise management on potential impacts and compliance requirements.</li></ul>Nutraceuticals (Plus Point)<ul><li>Review compliance documentation as per dietary supplement regulations (FDA/USP standards).</li><li>Support import approvals, labeling validation, ingredient verification, and claim assessments.</li></ul>Who Should Apply?Candidates with strong experience in Cosmetic Regulatory Affairs, US FDA MoCRA, ISO 22716, labeling compliance, and supplier documentation review are highly encouraged to apply.Apply Now: jobs@hrconsol.com Be part of a top-tier e-commerce brand scaling globally!Job Type: Full-timePay: Rs100,000.00 - Rs300,000.00 per monthWork Location: In person

Regulatory Affairs Specialist (Cosmetics, Skincare & Nutraceuticals)

Amerikan Hastanesi

<div>
 
 Stembio (
 
 Ko&ccedil; Holding/Ko&ccedil; Healthcare
 
 i&scedil;tiraki),
 
 Mezenkimal K&ouml;k H&uuml;creler (MSC), Eksozomlar, &Idot;mm&uuml;noterapi &Uuml;r&uuml;nleri, Kordon Kan&inodot; Bankalama ve Doku Greftleri
 
 &uuml;retimi ve haz&inodot;rlanmas&inodot; konusunda uzmanla&scedil;m&inodot;&scedil;, ileri teknolojiye sahip bir
 
 cGMP laboratuvar&inodot;d&inodot;r
 
 . Kalite kontrol ve validasyon s&uuml;re&ccedil;lerine b&uuml;y&uuml;k &ouml;nem vererek,
 
 y&uuml;ksek kaliteli ve reg&uuml;lasyonlara uygun
 
 h&uuml;cresel tedavi &uuml;r&uuml;nleri sunmay&inodot; taahh&uuml;t ediyoruz.
 
 
 
 
 
 Yenilik&ccedil;i &uuml;r&uuml;n portf&ouml;y&uuml;m&uuml;zde &mdash; ATMP&rsquo;ler, t&inodot;bbi cihazlar ve kozmetik s&inodot;n&inodot;f biyolojik &uuml;r&uuml;nler dahil &mdash; reg&uuml;lasyon stratejilerini y&uuml;r&uuml;tecek ve destekleyecek, erken geli&scedil;tirme a&scedil;amas&inodot;ndan klinik &ccedil;al&inodot;&scedil;ma izinlerine ve &uuml;r&uuml;n ticarile&scedil;tirmeye kadar t&uuml;m s&uuml;re&ccedil;lerde T&Idot;TCK, ard&inodot;ndan EMA (Avrupa) ve FDA (ABD) &ccedil;er&ccedil;evelerine uygun reg&uuml;lasyon uyumlulu&gbreve;unu sa&gbreve;lamaktan sorumlu
 
 Stembio
 
 'da g&ouml;revlendirilmek &uuml;zere bir
 
 Reg&uuml;lasyon Uzman&inodot;
 
 aray&inodot;&scedil;&inodot;nday&inodot;z.
 
 
 
 
 
 E&gbreve;er Ar-Ge, Kalite ve &Uuml;retim ekipleriyle yak&inodot;n i&scedil; birli&gbreve;i i&ccedil;inde &ccedil;al&inodot;&scedil;arak Stembio &uuml;r&uuml;nlerinin uluslararas&inodot; standartlara uygun ve hem yerel hem k&uuml;resel pazarlara haz&inodot;r hale getirilmesi konusunda yetkin oldu&gbreve;unuzu d&uuml;&scedil;&uuml;n&uuml;yorsan&inodot;z, ba&scedil;vurunuzu bekliyoruz!
 
 
 
 
 
 
 Genel Nitelikler
 
 
 
 
 
 <ul>
 <li>
 Biyolojik Bilimler, Biyoteknoloji, Eczac&inodot;l&inodot;k, Biyomedikal M&uuml;hendisli&gbreve;i, Kimya veya ilgili bir alanda lisans veya &uuml;zeri derece.
 </li>
 <li>
 Tercihen biyoteknoloji, ila&ccedil; veya t&inodot;bbi cihaz sekt&ouml;rlerinde en az 5 y&inodot;l Reg&uuml;lasyon alan&inodot;nda deneyim.
 </li>
 <li>
 ATMP, GMP, CE i&scedil;areti, MDR/IVDR ve klinik &ccedil;al&inodot;&scedil;ma d&uuml;zenlemeleri hakk&inodot;nda sa&gbreve;lam bilgi.
 </li>
 <li>
 K&uuml;resel reg&uuml;lasyon &ccedil;er&ccedil;evelerine h&acirc;kimiyet:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP ve cihaz kay&inodot;tlar&inodot;, klinik &ccedil;al&inodot;&scedil;ma izinleri
 
 
 
 Avrupa:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 K&uuml;resel:
 
 FDA (CBER), ICH k&inodot;lavuzlar&inodot;, ISO standartlar&inodot;
 
 
 
 
 <ul>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik belgeler ve klinik dok&uuml;mantasyon haz&inodot;rlama deneyimi.
 </li>
 <li>
 T&uuml;rk&ccedil;e ve &Idot;ngilizce yaz&inodot;l&inodot;/s&ouml;zl&uuml; ileti&scedil;im becerileri g&uuml;&ccedil;l&uuml;.
 </li>
 <li>
 &Ccedil;ok disiplinli ekiplerle &ccedil;al&inodot;&scedil;abilen, &ouml;ncelik y&ouml;netimi kuvvetli, dinamik ortamlarda etkin &ccedil;al&inodot;&scedil;abilen.
 </li>
 <li>
 Etik de&gbreve;erlere sahip, d&uuml;zenli, detaylara &ouml;nem veren ve reg&uuml;lasyon bilimi ile yenili&gbreve;e tutkulu.
 </li>
 </ul>
 
 
 
 
 
 Rol ve Sorumluluklar
 
 
 
 
 
 
 
 Reg&uuml;lasyon Stratejisi ve &Uuml;r&uuml;n Geli&scedil;tirme
 
 
 
 
 
 <ul>
 <li>
 Stembio&rsquo;nun &uuml;r&uuml;n portf&ouml;y&uuml; i&ccedil;in reg&uuml;lasyon stratejilerini geli&scedil;tirmek ve uygulamak.
 </li>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma onaylar&inodot;, GMP sertifikasyonlar&inodot; ve ruhsat ba&scedil;vurular&inodot;n&inodot; (T&Idot;TCK, EMA, FDA) planlamak ve y&ouml;netmek.
 </li>
 <li>
 Ba&scedil;vuru ve onay takvimlerini belirleyerek, i&ccedil; ekiplerle koordinasyon i&ccedil;inde hedeflenen lansman tarihlerine ula&scedil;&inodot;lmas&inodot;n&inodot; sa&gbreve;lamak.
 </li>
 <li>
 K&uuml;resel &uuml;r&uuml;n dosyalar&inodot;n&inodot; yerel reg&uuml;lasyon formatlar&inodot;na uyarlamak ve gerekli ek dok&uuml;mantasyonu haz&inodot;rlamak.
 </li>
 <li>
 Yeni endikasyonlar, teknoloji transferleri ve i&scedil; birlikleri i&ccedil;in reg&uuml;lasyon due diligence &ccedil;al&inodot;&scedil;malar&inodot;na destek vermek.
 </li>
 </ul>
 
 
 
 
 
 Reg&uuml;lasyon Uyumu ve Kurumsal &Idot;leti&scedil;im
 
 
 
 
 
 <ul>
 <li>
 T&uuml;rkiye, Avrupa Birli&gbreve;i ve ABD&rsquo;deki ATMP, t&inodot;bbi cihaz ve kozmetik mevzuatlar&inodot;ndaki geli&scedil;meleri takip etmek ve yorumlamak.
 </li>
 <li>
 Reg&uuml;lasyon kurumlar&inodot;yla (T&Idot;TCK, EMA, FDA, Onaylanm&inodot;&scedil; Kurulu&scedil;lar) aktif ileti&scedil;im y&uuml;r&uuml;tmek, denetimlerde ve incelemelerde Stembio&rsquo;yu temsil etmek.
 </li>
 <li>
 GMP ve reg&uuml;lasyon denetimlerine y&ouml;nelik haz&inodot;r olma durumunu sa&gbreve;lamak, denetim cevaplar&inodot;n&inodot; ve CAPA s&uuml;re&ccedil;lerini y&ouml;netmek.
 </li>
 <li>
 T&uuml;rkiye ve AB&rsquo;de ATMP alan&inodot;ndaki reg&uuml;lasyon &ccedil;er&ccedil;evesini &scedil;ekillendiren sekt&ouml;r giri&scedil;imlerinde aktif rol almak.
 </li>
 </ul>
 
 
 
 
 
 Standartlar, Sertifikasyon ve Dok&uuml;mantasyon
 
 
 
 
 
 <ul>
 <li>
 Ge&ccedil;erli uluslararas&inodot; standartlara (ISO 13485, ISO 10993, EN, IEC, ICH Q serisi) ve y&ouml;netmeliklere (CE i&scedil;areti, MDSAP, MDR, IVDR) uygunlu&gbreve;u sa&gbreve;lamak.
 </li>
 <li>
 &Uuml;r&uuml;n kay&inodot;t dosyalar&inodot;, teknik dok&uuml;mantasyon, etiketleme ve kullan&inodot;m k&inodot;lavuzlar&inodot;n&inodot; haz&inodot;rlamak, g&ouml;zden ge&ccedil;irmek ve g&uuml;ncel tutmak.
 </li>
 <li>
 Sertifikasyon s&uuml;re&ccedil;lerini (&ouml;r. CE, TSE, Eurovent, PED) koordine etmek; akredite test laboratuvarlar&inodot; ve sertifikasyon kurulu&scedil;lar&inodot;yla ileti&scedil;imi y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 Klinik &Ccedil;al&inodot;&scedil;malar ve Pazar Sonras&inodot; Faaliyetler
 
 
 
 
 
 <ul>
 <li>
 Klinik &ccedil;al&inodot;&scedil;ma ba&scedil;vurular&inodot;, tadilatlar&inodot; ve yenilemelerini T&Idot;TCK ve EMA &ccedil;er&ccedil;evelerinde desteklemek.
 </li>
 <li>
 ATMP&rsquo;lere y&ouml;nelik k&uuml;resel klinik ara&scedil;t&inodot;rma ortam&inodot;n&inodot; takip etmek ve Klinik &Ccedil;al&inodot;&scedil;ma Yetkilendirmesi (CTA) dosyalar&inodot;n&inodot;n haz&inodot;rlanmas&inodot;na katk&inodot; sa&gbreve;lamak.
 </li>
 <li>
 Onayl&inodot; &uuml;r&uuml;nler i&ccedil;in pazar sonras&inodot; g&ouml;zetim, g&uuml;venlilik raporlamas&inodot; ve s&uuml;rekli emniyet g&uuml;ncellemelerini y&uuml;r&uuml;tmek.
 </li>
 </ul>
 
 
 
 
 
 &Idot;&ccedil; Kalite ve S&uuml;re&ccedil; Entegrasyonu
 
 
 
 
 
 <ul>
 <li>
 Reg&uuml;lasyon ve GMP standartlar&inodot;na uygunlu&gbreve;u sa&gbreve;lamak &uuml;zere i&ccedil; denetimler ger&ccedil;ekle&scedil;tirmek.
 </li>
 <li>
 Kalite G&uuml;vence, Ar-Ge, &Uuml;retim ve Hukuk ekipleriyle i&scedil; birli&gbreve;i i&ccedil;inde &uuml;r&uuml;n ya&scedil;am d&ouml;ng&uuml;s&uuml;n&uuml;n her a&scedil;amas&inodot;nda reg&uuml;lasyon entegrasyonunu sa&gbreve;lamak.
 </li>
 <li>
 Uyumsuzluk risklerini tespit etmek ve proaktif &ouml;nleme stratejileri geli&scedil;tirmek.
 </li>
 </ul>
 
 
 
 
 
 Ki&scedil;isel verileriniz, i&scedil; ba&scedil;vurunuzun al&inodot;nmas&inodot; ve de&gbreve;erlendirmesi amac&inodot;yla i&scedil;lenmektedir. &Idot;&scedil;lenen ki&scedil;isel verilerinize ve haklar&inodot;n&inodot;za ili&scedil;kin detayl&inodot; bilgilere websitemizin &ldquo;&Idot;nsan Kaynaklar&inodot;&rdquo; ba&scedil;l&inodot;&gbreve;&inodot; i&ccedil;erisinde yer alan&ldquo;&Ccedil;al&inodot;&scedil;an Aday&inodot; Ayd&inodot;nlatma Metni&rsquo;nden ula&scedil;abilirsiniz.
 
 
 
 
 
 
 -------------------------------------------------------------------------------------------------------------
 
 
 
 
 
 Stembio (a Koc Holding/Koc Healthcare company) is a cutting-edge cGMP laboratory specializing in the production and preparation of Mesenchymal Stem Cells (MSCs), Exosomes, Immunotherapy Products, Cord Blood Banking, and Tissue Grafts. We are committed to delivering high-quality, regulatory-compliant cell therapy products through rigorous quality control and validation processes.
 
 
 
 
 
 We are seeking for a qualified and experienced
 
 Regulatory Affairs Specialist
 
 
 for Stembio,
 
 who
 
 
 will be responsible for ensuring regulatory compliance from early development to clinical trial authorization and product commercialization, initially under Turkish Medicines and Medical Devices Agency (T&Idot;TCK), and subsequently through EMA (Europe) and FDA (U.S.) frameworks,
 
 
 to lead and support regulatory strategies across Stembio&rsquo;s innovative product lines &mdash; including ATMPs, medical devices, and cosmetic-grade biologics.
 
 
 
 
 
 If you are passionate about creating close collaboration with R&amp;D, Quality, and Production teams to ensure Stembio&rsquo;s products meet international standards and are launch-ready for both local and global markets, we encourage you to apply!
 
 
 
 
 
 
 Qualifications
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s or higher degree in Biological Sciences, Biotechnology, Pharmacy, Biomedical Engineering, Chemistry, or a related discipline.
 </li>
 <li>
 Minimum 5 years of experience in Regulatory Affairs, ideally within the biotechnology, pharmaceutical, or medical device sectors.
 </li>
 <li>
 Solid understanding of ATMP, GMP, CE marking, MDR/IVDR, and clinical trial regulations.
 </li>
 <li>
 Familiarity with global regulatory frameworks:
 </li>
 </ul>
 
 
 
 
 
 T&uuml;rkiye:
 
 T&Idot;TCK (ATMP and Device Registration, Clinical Trial Authorization)
 
 
 
 Europe:
 
 EMA (CAT, EudraCT, EudraVigilance)
 
 
 
 Global:
 
 FDA (CBER), ICH guidelines, ISO standards
 
 <ul>
 <li>
 Experience in preparing and maintaining product registration files, technical documentation, and clinical dossiers.
 </li>
 <li>
 Strong communication skills in Turkish and English (both written and spoken).
 </li>
 <li>
 Ability to work effectively in cross-functional teams and manage multiple priorities in a dynamic environment.
 </li>
 <li>
 Ethical, organized, and detail-oriented mindset with a passion for regulatory science and innovation.
 </li>
 </ul>
 
 
 
 
 
 Key Responsibilities
 
 
 
 
 
 
 
 Regulatory Strategy &amp; Product Development
 
 
 
 
 
 <ul>
 <li>
 Develop and execute regulatory strategies for Stembio&rsquo;s Product Pipeline.
 </li>
 <li>
 Plan and manage regulatory submissions for clinical trial approvals, GMP certifications, and marketing authorizations under T&Idot;TCK, EMA, and FDA.
 </li>
 <li>
 Define submission and approval timelines, coordinating with internal teams to meet launch targets.
 </li>
 <li>
 Adapt global product dossiers to local regulatory formats and gather supplementary documentation as needed.
 </li>
 <li>
 Support regulatory due diligence for new indications, technology transfers, and collaborations.
 </li>
 </ul>
 
 
 
 
 
 Regulatory Compliance &amp; Institutional Liaison
 
 
 
 
 
 <ul>
 <li>
 Monitor and interpret evolving legislation on ATMPs, medical devices, and cosmetics across T&uuml;rkiye, EU, and the U.S.
 </li>
 <li>
 Maintain active communication with regulatory bodies (T&Idot;TCK, EMA, FDA, Notified Bodies) and represent Stembio during inspections and audits.
 </li>
 <li>
 Ensure inspection-readiness for GMP and regulatory audits; manage audit responses and CAPAs.
 </li>
 <li>
 Engage with industry associations to support advocacy initiatives shaping the Turkish and EU ATMP landscape.
 </li>
 </ul>
 
 
 
 
 
 Standards, Certification &amp; Documentation
 
 
 
 
 
 <ul>
 <li>
 Ensure compliance with applicable international standards (ISO 13485, ISO 10993, EN, IEC, ICH Q-series) and directives (CE marking, MDSAP, MDR, IVDR).
 </li>
 <li>
 Prepare, review, and maintain technical documentation, including product registration files, device master records, labeling, and instructions for use.
 </li>
 <li>
 Coordinate certification processes (e.g., CE, TSE, Eurovent, PED) and liaise with accredited test laboratories and certification bodies.
 </li>
 </ul>
 
 
 
 
 
 Clinical Trials &amp; Post-Market Activities
 
 
 
 
 
 <ul>
 <li>
 Support clinical trial submissions, amendments, and renewals under T&Idot;TCK and EMA frameworks.
 </li>
 <li>
 Track the global clinical trial landscape for ATMPs and contribute to dossier compilation for Clinical Trial Authorization (CTA).
 </li>
 <li>
 Oversee post-market surveillance, vigilance reporting, and continuous safety updates for approved products.
 </li>
 </ul>
 
 
 
 
 
 Internal Quality &amp; Process Integration
 
 
 
 
 
 <ul>
 <li>
 Conduct internal audits to ensure adherence to regulatory and GMP standards.
 </li>
 <li>
 Collaborate with Quality Assurance, R&amp;D, Production, and Legal teams to ensure full regulatory integration across the product lifecycle.
 </li>
 <li>
 Identify compliance risks and develop proactive mitigation strategies.
 </li>
 </ul>
 
 
 
 
 
 Your personal data is processed for the purpose of receiving and evaluating your job application. You can find detailed information about your processed personal data and rights from the "Employee Candidate Clarification Text" under the "Human Resources" heading of our website.
 
 
</div>

Stembio - Regülasyon Uzmanı / Regulatory Affairs Specialist

Perrigo

<div>At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. 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 The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill&reg;, Compeed&reg;, Solpadeine&reg;, NiQuitin&reg;, ACO&reg;, and many more. We Are Perrigo. 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. 
Join us on our One Perrigo journey as we evolve to win in self-care.<div><div><div><h2 class="jobSectionHeader"> 
Description Overview</h2></div><div>
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.</div></div><div><div><h2 class="jobSectionHeader">
Scope of the Role</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">
Experience Required</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>
Benefits 
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.
Find out more about Total Rewards at Perrigo. 
Hybrid Working Approach 
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. 
We are proud to be included in the Forbes list of &quot;America's Best Employers by State 2024&quot;. Find out more here 
Applicants please note: 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. 
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</div>

Regulatory Affairs, Associate Specialist

Abbott

<div><div>About Abbott
Abbott is a global healthcare leader that is creating breakthrough science to improve people&rsquo;s health. We&rsquo;re always looking towards the future, anticipating changes in medical science and technology.
Working at Abbott
At Abbott, you can do work that matters, grow and learn, care for yourself and your family, be your true self, and live a full life. You will have access to:<ul><li>
Career development with an international company where you can grow your dream career.</li><li>
A company recognized as a great place to work in dozens of countries worldwide and named one of the most admired companies by Fortune.</li><li>
A company recognized as one of the best big companies to work for and the best place to work for diversity, working mothers, female executives, and scientists.</li></ul>
The Opportunity - Regulatory Affairs Senior Specialist- GEM &amp; Levant
This position works out of our UAE office in the Established Pharmaceutical division.
This is a fixed term contract role for 1 year.
About Established Pharmaceuticals&mdash;We are committed to bringing the benefits of our trusted medicines to more people in the world&rsquo;s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines covers multiple therapeutic areas, including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.</div><div><div><div><div><div><div><div><div><div><div><div><div><div><div>
As Regulatory Affairs Senior Specialist, you'll be responsible for preparation and submission of dossiers according to country specific requirements and regulations.
What you'll do-
Regulatory Affairs Coordination<ul><li>
Follow up on regulatory activities and plans for the assigned countries, renewal registration, registration, variation changes, safety updates, pricing, labelling and site transfers.</li><li>
Responsible for preparation and submission of dossiers according to country specific requirements and regulations.</li><li>
Provide regulatory support for tender business.</li><li>
Respond to agency questions and develops/coordinates appropriate responses.</li><li>
Initiate the pricing documents based on each country's needs.</li><li>
Develop and create new labelling printout according to country's regulations for our core products without any disruption of the existence of these products.</li><li>
Communicate the updated patient Information Leaflet.</li><li>
Review promotional materials and submit to the agency in countries where MOH approvals are required.</li><li>
Handle promotional material&rsquo;s submission in MOH UAE.</li><li>
Interaction with health authorities throughout the lifecycle of products.</li><li>
Provide guidance to peers and other external partners.</li><li>
Coordinate regulatory organization processes with different partners in different countries.</li><li>
Communicate efficiently with all business partners and employees</li><li>
Act as regulatory representative on project teams and provide advice on specific projects contributing to the development of project plans and target product profiles.</li><li>
Support, backup, solve, challenge, negotiate, act, plan and restore global and country specific regulations and information.</li><li>
Re-challenge the HA and regulatory responsible on the variation&rsquo;s tools and laws</li></ul>
Required Qualifications:
Bachelor&rsquo;s degree of Pharmacy
Year of experience: 2-5 years
Experience in Regulatory Affairs . Registration requirement knowledge, Communication skills and analytical mindset,
Arabic &amp; English language
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.</div></div></div></div></div></div></div></div></div></div></div></div></div></div></div>

Regulatory Affairs Senior Specialist-GEM & Levant

Servtech Technical Services llc

Job SummaryThe Government Relations and Regulatory Affairs Specialist ensures the company operates in full compliance with UAE laws, handles all licensing and regulatory requirements, coordinates with government authorities, and enforces safety standards across sites and vehicles. The role demands strict discipline, accuracy, and continuous monitoring of regulatory changes.Key Responsibilities1. Government Relations, Licensing &amp; Legal Compliance<ul><li>Process and manage all visa, work permit, residency, immigration, and MOHRE transactions.</li><li>Renew and update trade licenses, establishment cards, and tenancy contracts.</li><li>Maintain complete records for all employee documents and regulatory renewals.</li><li>Track and implement changes in UAE labor and immigration regulations.</li><li>Ensure all permits, certificates, and compliance documents remain valid.</li></ul>2. Health &amp; Safety Oversight<ul><li>Enforce mandatory PPE usage across all employees.</li><li>Conduct safety inspections and ensure hazard-free worksites.</li><li>Ensure proper use and maintenance of tools and equipment.</li><li>Enforce reporting of hazards, near-misses, and incidents.</li><li>Monitor completion of safety training and emergency preparedness.</li></ul>3. Vehicle &amp; Site Safety<ul><li>Perform routine inspections of company vehicles (brakes, lights, tires, load securing, etc.).</li><li>Ensure only authorized, licensed drivers operate company vehicles.</li><li>Control vehicle access, site movement, and safe parking.</li><li>Monitor vehicle cleanliness and maintenance and issue NCRs when required.</li><li>Investigate vehicle-related incidents and enforce corrective actions.</li></ul>Mandatory RequirementDriving License (Compulsory)<ul><li>Valid UAE Driving License is mandatory for this role.</li><li>Daily responsibilities require frequent travel to government departments, sites, workshops, and offices.</li><li>Candidate must be fully capable of operating company vehicles safely and professionally.</li></ul>Skills &amp; Qualifications<ul><li>Strong knowledge of UAE government procedures (MOHRE, Immigration, DED, Tasheel, etc.).</li><li>Experience in regulatory affairs, licensing, and government liaison work.</li><li>Solid understanding of HSE rules and vehicle/site safety practices.</li><li>Strong communication and documentation skills.</li><li>Ability to manage deadlines, compliance schedules, and high-volume tasks.</li><li>Valid UAE Driving License &ndash; Mandatory.</li></ul>Job Type: Full-timePay: AED3,000.00 - AED3,500.00 per month

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