Manager-Biologics Regulatory Affairs(Clinical Trials)

About USV Private Limited :

USV, a top-15 pharmaceutical company in India, excels in the diabetes and cardio sectors and has presence in over 65 countries.

Function : Biologics

Position : Asst Manager / Manager - Regulatory Affairs (Clinical Trials) For EU and US.

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

Desired Qualification : M.Pharm / B.Pharm

Desired Work Experience : 5-15 years in RA-Clinical Trials for EU and US markets.

Job Responsibilities :

1. Biosimilar Clinical Development Strategy, Clinical trials, injectables for EU and US markets.

2. Biosimilar Clinical design and Protocol development, review and finalization for EU and US markets.

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

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

5. MOH Query response

6. Product Life cycle Management

7. RA support for Plant related QMS activities