Regulatory Affairs Executive
4 days ago
Key Responsibilities:1. Develop the global regulatory strategies for biologic products across all development phases (preclinical to post-marketing) for the (US, EU, and ROW).2. Ensure alignment with business goals and regulatory requirements across the different regions. (FDA, EMA, emerging markets).3. Prepare, review, and manage high-quality regulatory submissions including INDs/IMPDs, BLA/MAA, CTA, DSUR, Annual Reports, as applicable.4. Post-approval changes (variations, amendments).5. Liaise with global regulatory agencies to facilitate product approvals and resolve queries.6. Collaborate with R&D, Quality, Clinical, and national regulatory teams to ensure regulatory compliance across product lifecycle.7. Provide regulatory guidance during product development, tech transfer, and clinical trial execution, as appropriate.8. Monitor and interpret evolving global regulations, guidelines, and industry trends related to product category.9. Provide interpretive analyses of regulatory guidance, regulations, or directives that impact product(s) or CMC operations.Qualifications:1. Master's degree (M.Sc./M.Pharm/M.Tech) in Life Sciences, Biotechnology, Pharmaceutical Sciences, or related discipline.2. Minimum 5-7 years of regulatory affairs experience, with a strong focus on biologics (including mAbs, biosimilars, vaccines, or novel biologics) in the emerging markets.3. Solid understanding of ICH guidelines, FDA, EMA, and other emerging market regulatory frameworks.4. Experience in IND / BLA submissions, and lifecycle management of biological products.
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Executive - Regulatory Affairs
2 days ago
Delhi, Delhi, India Domnic Lewis Pvt. Ltd Full time**Executive - Regulatory Affairs - Delhi**: **Domnic Lewis has been mandated to hire for Executive - Regulatory Affairs - Delhi** **Position Title**: Executive - Regulatory Affairs **Grade**: C **Reports to**: Lead/Manager - Regulatory Affairs **Position Purpose**: - Monitor and report the status of all product licenses in a timely and accurate manner -...
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Regulatory Affairs Executive
7 days ago
Delhi, Delhi, India SAVVI SALES AND SERVICE PVT.LTD. Full timeJob Title: Regulatory Affairs Executive Location: Rohini, Delhi Industry: Pharmaceuticals / Nutraceuticals Salary Package: ₹25,000 - ₹50,000 per month Gender Preference: Male Experience Required: 2-3 years in Pharma or Nutra Industry (Regulatory Affairs) Key Responsibilities: - Prepare and submit regulatory dossiers such as INDs, NDAs, ANDAs,...
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Regulatory Affairs Executive
1 week ago
Delhi, India NKG ADVISORY BUSINESS AND CONSULTING SERVICES PVT LTD Full timeJob Description - **Regulatory Affairs Executive Medical Devices** As a Manager - Regulatory and Government Affairs for Medical Devices, you would be expected to actively engage with government stakeholders and regulatory bodies to ensure crisp and effective representation on regulatory and policy matters and ensure continuity of license and permits as well...
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Regulatory Affairs Manager
3 days ago
New Delhi, India Ixoreal Biomed Full timeAbout the Company : Shri Kartikeya Pharma is one of India’s leading nutraceutical companies, specializing in the manufacture of high-quality dietary supplement ingredients derived from root extracts.Title: Manager/Senior Manager- Global Regulatory Affairs Experience: 8–12+ yearsof Regulatory Affairs experience in Nutraceuticals, Dietary Supplements,...
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Regulatory Affairs Associate
2 weeks ago
New Delhi, India HCLTech Full timeExperience: 2 to 5 yearsEducation: Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles in Quality Assurance, Regulatory Affairs, and Documentation in the Medical Devices domain.Skills & Requirements:Minimum 3 years of experience in Medical Devices Regulatory Affairs, Quality Assurance, or Documentation-...
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Regulatory Affairs Executive
4 weeks ago
New Delhi, India Halma plc Full timeAbout Halma: Halma is a global group of life-saving technology companies, driven by a clear purpose. We are an FTSE 100 company with headquarters in the UK and operations in 23 countries, including regional hubs in India, China, Brazil, and the US. Our diverse group of nearly 50 global companies specialize in market leading technologies that push the...
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Regulatory Affairs Executive
7 days ago
Mangolpuri A Block, Delhi, Delhi, India EDUSOFT HEALTHCARE PRIVATE LIMITED Full time**Edusoft Healthcare Pvt. Ltd.** **Company Profile**: Edusoft Healthcare is a leading provider of innovative medical solutions since 2016. We have exclusive partnerships with industry leaders, Carestream Health Inc., USA, LG Electronics, and Genworks Health, India to bring the latest medical technologies to our customers. With a PAN India presence, our team...
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Regulatory Affairs Specialist
1 week ago
New Delhi, India Gentell Full timeGentell is one of the largest vertically integrated wound care companies in the world. Based in Yardley, PA and with offices, distribution centers and manufacturing plants around the world, our purpose is to make a positive difference in the quality of life for the injured, the chronically ill and those near the end of life.Our success is a result of the...
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Regulatory Affairs Associate
3 weeks ago
New Delhi, India HCLTech Full timeExperience:2 to 5 years Education:Bachelor's degree in Biomedical, Mechanical, or B.PharmWe are looking for talented professionals for roles inQuality Assurance ,Regulatory Affairs , andDocumentationin theMedical Devicesdomain.Skills & Requirements: Minimum 3 years of experience in Medical DevicesRegulatory Affairs ,Quality Assurance , orDocumentation Strong...
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Regulatory Affairs Executive
2 days ago
Delhi, Delhi, India Ample Leap Cognition & Technologies Pvt Ltd Full timeDESIGNATION/ TITLE Sr. Executive / Assistant Manager - Regulatory Affairs LOCATION NSP, Delhi YEAR OF EXP Minimum 3 yrs QUALIFICATION MSc (Toxicology/Agri/Chem) or similar BUDGET In b/w 8-10Lpa KEY RESPONSIBILITIES ROLES & RESPONSIBILITIES Manage the data gathering and compilation of studies (toxicology, chemical, efficacy) necessary for the submission and...
