Senior Manager Regulatory Affairs
4 weeks ago
Position: Sr. Manager / AGM – Regulatory Affairs Qualification: M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory compliance/audit support. The role ensures accurate and compliant representation in dossiers, while guiding strategy for regulatory filings, variations, and lifecycle management across multiple regions.Key ResponsibilitiesDeep expertise in vaccine/biological regulatory affairs, dossier preparation, and lifecycle management.Strong track record in WHO PQ filings, country registrations in LatAm & Africa, and handling audits/inspections.Hands-on experience in CMC data review, comparability, and technology transfer from development to commercial sites.Skilled in managing confidential proprietary know-how within regulatory frameworks.Leadership ability to guide teams, engage with regulators, and drive cross-functional compliance.Prepare and review CTD/ACTD/eCTD dossiers, ensuring accuracy and compliance with regional requirements.Confidential Know-How Custodian: Manage proprietary technical information (cell substrates, seeds, process steps, validation data, excipients, DS/DP composition) and ensure controlled incorporation into dossiers.Lead post-approval variations, change controls, and license renewals/maintenance across client countries.Drive pre-submission strategy, dossier compilation, regulatory liaison, and post-PQ lifecycle management.Provide country-specific CMC requirements to R&D; guide teams on comparability, validation, and regulatory responses.Ensure regulatory guidance and documentation compliance during product/site transfers/Tech transfer.Prepare responses to regulatory queries, coordinate with bulk suppliers for PAC filings, and represent the company during inspections.Mentor and upskill subordinates; build regulatory capability aligned to evolving global requirements.Liaison with Regulatory AuthoritiesCandidate ProfileProven expertise in vaccine/biological product regulatory affairs, including WHO PQ and multi-regional registrations.Strong knowledge of CMC, comparability, process validation, and lifecycle change management.Experience liaising with regulators, managing audits, and preparing PSURs/SAE submissions.Ability to lead teams, safeguard confidential technical know-how, and drive regulatory compliance across geographies.
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Senior manager regulatory affairs
4 weeks ago
New Delhi, India Panacea Biotec Full timePosition: Sr. Manager / AGM – Regulatory AffairsQualification: M. Sc. / Ph. D. (Life Sciences, Biotechnology, or related discipline)Experience: 13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (Lat Am, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
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Regulatory Affairs Manager
1 day ago
New Delhi, India Chemill Pharma Ltd. Full timePurpose of the Role:Chemill Pharma is seeking a seasoned and detail-oriented Regulatory Affairs Manager to lead and oversee all regulatory activities across ASEAN markets and Hong Kong, while providing regional support for other territories as needed. The ideal candidate will have strong experience in managing end-to-end product registrations, leading teams,...
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Senior Manager Regulatory Affairs
1 week ago
Delhi, Delhi, India Panacea Biotec Full time ₹ 12,00,000 - ₹ 36,00,000 per yearPosition:Sr. Manager / AGM – Regulatory AffairsQualification:M.Sc. / Ph.D. (Life Sciences, Biotechnology, or related discipline)Experience:13–16 years in Regulatory Affairs (vaccines/biologicals)Role:The role is responsible for global product registrations (LatAm, Africa, GCC etc.), WHO Prequalification, Product lifecycle management, and regulatory...
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Regulatory Affairs Specialist
4 weeks ago
New Delhi, India Frisch Medical Devices PVT LTD Full timeJob Title: Regulatory Affairs Junior ManagerLocation:At Ahmedabad Office , Near Thaltej Crossroads Department:RA Reports To:RA Head and Regulatory Department at HO /Director Employment Type:Full Time Office hours : 9,30 AM to 6 PM Week of: Sunday andSaturday Half Day Preferred Gender: M/F Experience : Minimum 2 yearsJob Summary: We are seeking a proactive...
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Regulatory Affairs Manager
6 days ago
Delhi, Delhi, India Ace Cathtech Pvt. Ltd. Full time ₹ 6,00,000 - ₹ 9,00,000 per yearCompany DescriptionAce Cathtech Pvt Ltd, established in April 2024, is a cutting-edge manufacturer of premium medical devices, specializing in Nephrology Products, Cardiac Surgery Equipment, Critical Care, and Anesthesia Products. Located in Faridabad, Haryana, our state-of-the-art facility adheres to the highest manufacturing standards, including a Class 7...
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Regulatory Affairs Specialist
1 week ago
New Delhi, India Shiv Nadar School Full timeJob Title: Senior Manager – Regulatory Affairs & Legal CompliancesLocation: Core Office, NoidaEmployment Type: Full-timeJob Summary:We are seeking a detail-oriented and proactive professional to oversee the organization’s legal, regulatory, and compliance functions. The incumbent will be responsible for ensuring adherence to statutory requirements,...
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Regulatory Affairs Manager
4 weeks ago
New Delhi, India Kimirica Hunter International Full timeJob Title:Manager – Regulatory and ComplianceLocation:Indore Department:Regulatory AffairsRole Overview: Kimirica Hunter International is seeking a highly skilledManager – Regulatory and Complianceto lead and oversee the compliance function for our diverse product portfolio. The ideal candidate will bring extensive expertise in regulatory requirements...
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Regulatory Affairs Associate
1 day 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 Manager
6 hours ago
Delhi, Delhi, India Wembrace Biopharma Private Limited Full time ₹ 12,00,000 - ₹ 36,00,000 per yearJob ProfileThe Regulatory Affairs Manager (RAM) for Africa, MENA, and LATAM will lead regulatory strategy, submissions, approvals, and life-cycle management of pharmaceutical, biotech, and nutraceutical products across these diverse regions. The role requires a strong understanding of local health authority requirements, WHO guidance, and international...
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Regulatory affairs manager
3 weeks ago
New Delhi, India SOZIO Full timeCompany :Founded in 1758 in Grasse in the south of France, Maison Sozio is one of the pioneers in fine French perfumery.The history of the Maison Sozio goes back to one of the very first families of perfumers in Grasse, having been at the origin of the community of glove-makers and perfumers.With the integration of Synarome in 2021, Sozio ties back to its...
