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Manager (CMC)-RA

8 - 13 years

10 - 20 Lacs

Mumbai

Posted:3 months ago| Platform: Naukri logo

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Skills Required

Biologics Biosimilar Regulated Markets EU Dossier Authoring Regulatory Affairs eCTD submissions MOH Query response US

Work Mode

Work from Office

Job Type

Full Time

Job Description

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

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Venture Capital

New York

20-50 Employees

32 Jobs

    Key People

  • Fred Wilson

    Co-Founder & Partner

  • Brad Burnham

    Co-Founder & Partner

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