Manager Biologics-RA-CMC - (EU & US)

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 : Manager - Regulatory Affairs (CMC)-EU & US markets

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

Desired Qualification : M.Pharm / B.Pharm

Desired Work Experience : 5-10 years

Candidate should be from Biologics / Biosimilars

• Regulatory support and review for pre-filing and development documentation for EU and US.
• Coordination with internal and external stakeholders for regulatory filing related documentation for EU and US.
• Review, compilation and authoring of Sterility Assurance and Sterile Process Validation for EU and US.
• Review of plant and R&D documentation such as BMR, BPR, Specifications etc
• Authoring, compilation and review of ANDA dossier in eCTD format, followed by publishing, validation and submission of dossier for EU and US.
• Post approval filing such as supplement and annual report