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Manager (CMC)-RA USV

8 - 13 years

10 - 20 Lacs

Mumbai

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Function: Biologics Position: Regulatory Affairs- CMC Job Location: Govandi (East ), Mumbai (2nd & 4th Saturday off, 1st, 3rd and 5th Saturday working) Desired Qualification: M.Pharm/B.Pharm Desired Work Experience: 8-12 years Job Responsibilities: 1. Biosimilar Regulated market submissions - US / EU market submission 2. Biosimilar Product Development Strategy for CMC and Clinical 3. Review of all Dosisier related Quality documents inclusing coordination with Cross functional teams ( R&D, QC/QA and Manufacturing) 4. Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions 5. MOH Query response 6. Biosimilar Product Life Cycle Management 7. RA support for Plant related QMS activities

Posted 3 months ago

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