Manager- Biologics RA-Clinical Trials

8 hours ago


Mumbai, Maharashtra, India USV Full time ₹ 15,00,000 - ₹ 25,00,000 per year

USV, a top-15 pharmaceutical and biotechnology company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries and is a leading producer of Metformin in India.

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Function: Biologics

Position: Deputy Manager/Manager - Regulatory Affairs (Clinical)

Job Location: Govandi (East ), Mumbai (1st, 3rd, 5th Saturday working, 2nd and 4th Saturday off))

Desired Qualification: M.Pharm/B.Pharm

Desired Work Experience: 8-15 years

Job Responsibilities:

  1. Biosimilar Clinical Development Strategy, Clinical trials, injectables

  2. Biosimilar Clinical design and Protocol development, review and finalization

  3. Biosimilar Clinical Trial Application, Overview of clinical study conduct, Clinical Study report review and finalization

  4. Biologics/Biosimilar Dossier Authoring, Review and Hands on experience in eCTD submissions

  5. MOH Query response

  6. Product Life cycle Management

  7. RA support for Plant related QMS activities



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