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

Must Haves:

A minumum of 4 years experience in the below:

US & EU registration for Biosimilars

Regulatory experience for both drug substance and drug product for USFDA and EMA

Intial dossier authoring for modules I - III of CMC for EU & US

Biosimilar filing for EU & US

Authoring pre approval dossiers for US and EU.

MOH query response for both Drug Substance and Drug Product.

If from Small Molecules

Strong xperience in Small Molecule Injectables registrations for the US market

Strong experience in MOH query response for both Drug Substance and Drug Product.

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.