Regulatory Affairs Manager- SME
3 weeks ago
Domain lead - SME - Safety and Regulatory-BA offshore Expert in Pharma domain’s multiple functions especially Regulatory and Safety Well versed with business functions and tools used by industry Able to create integrated solutions and able to address customer pain points Able to draw process flows Act as Technical Product Owner for global regulatory systems and solutions, ensuring alignment with business goals and compliance requirements. Gather, analyze, and document business requirements from regulatory stakeholders across global regions, ensuring clarity and completeness. Facilitate workshops, requirement-gathering sessions, and backlog grooming Drive solution design discussions, ensuring integration with existing regulatory, safety and submission management platforms. Ensure adherence to pharmaceutical regulatory frameworks (e.g., FDA, EMA, ICH) and compliance with data integrity and GxP standards. Have knowledge of FDA, EMA and other agency’s rules and regulations Provide thought leadership on digital tools and process optimization in the global regulatory affairs space as well as Safety signal identification and assessment. Be the go-to person for customers and Account team for any functional knowledge on Regulatory and Safety Have 10+ years of relevant experience
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Senior Manager Regulatory Affairs
4 weeks ago
New Delhi, India Panacea Biotec Full timePosition: 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...
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Regulatory Affairs Manager
2 days 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
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 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 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
2 days 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
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...
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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...
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Regulatory Affairs Associate
2 days ago
Delhi, Delhi, India Intrinseque Health Full time ₹ 8,00,000 - ₹ 12,00,000 per yearThe Regulatory Affairs Associate will manage the preparation, review, and submission of regulatory documents to ensure compliance with applicable regulations. The role will involve monitoring adherence to regulatory requirements, staying updated on relevant guidelines, and providing strategic input on regulatory matters.QualificationsKnowledge of Regulatory...