Regulatory Affairs Manager Batavia Pharma Pvt Ltd

8.0 - 12.0 years

8 - 12 Lacs

pune

Work from Office

Role & responsibilities Role Overview: The Regulatory Affairs Manager will be responsible for overseeing all regulatory aspects of projects, ensuring compliance with global guidelines, and leading regulatory submission. Responsible for preparing, reviewing, and compiling high-quality CMC (Chemistry, Manufacturing, and Controls) documentation for regulatory submissions (CTD/eCTD) in line with EU/UK/and other global regulatory requirements. The role requires close coordination with cross-functional teams (Formulation, Analytical, Quality, Production, and Packaging) to ensure timely and compliant dossier submissions. Responsibilities : Compile, review, and manage dossiers (Modules 1-5) for regu...

Posted 1 week ago

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Senior Executive - Regulatory Affairs Job Network

5.0 - 7.0 years

6 - 10 Lacs

mumbai

Work from Office

Department : Regulatory Affairs Should be from Pharmaceutical/Lifesciences Industry. Job Overview: We are looking for an experienced and detail-oriented Senior Executive Regulatory Affairs (RA) to join our team. The ideal candidate will be responsible for compiling, reviewing, and submitting regulatory dossiers for both ROW and regulated markets in compliance with EU CTD guidelines. This role demands a strong understanding of global regulatory requirements, coordination across cross-functional teams, and the ability to independently handle client and authority queries. Key Responsibilities : Prepare master dossiers as per EU CTD (Common Technical Document) guidance. Review key regulatory doc...

Posted 3 weeks ago

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Senior Executive - Regulatory Affairs Job Network Mumbai

5.0 - 7.0 years

6 - 10 Lacs

mumbai

Work from Office

Posted Date not available

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