Biologics, Regulatory Affairs- CMC

About the Company

USV

About the Role

Function: Biologics, Regulatory Affairs

Position: Deputy Manager/Manager/Senior Manager - Biologics Regulatory Affairs- CMC

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

Qualifications

• Desired Qualification: M.Pharm/B.Pharm
• Desired Work Experience: Candidates having at least 6 - 10 years of experience in US and EU market registrations for Biosimilar therapeutic proteins and Monoclonal Antibodies. Alternatively, candidates having at least 8 - 10 years of experience in Small molecules injectables registrations for the US market with dossier authoring and query response for both drug substance and drug product.

Responsibilities

• Biosimilar Regulated market submissions - US / EU regulatory submission.
• Biosimilar Dossier Authoring (Drug substance and Drug product), MOH query response and Hands on experience in eCTD submissions.
• Biosimilar Product Development Strategy for CMC and Clinical development.
• Review of Quality documents including coordination with Cross functional teams (R&D, QC/QA and Manufacturing).
• Biosimilar Product Life Cycle Management.
• RA support for Plant related QMS activities.