Job Title Associate Manager/ Manager – Regulatory Affairs (CMC – Drug Substance)
Function Global Regulatory Affairs – CMC
Location Bangalore, India
Role Purpose
The role supports development, registration, and lifecycle management of CMC activities for biologics/biosimilars. The incumbent will work closely with senior regulatory colleagues and cross-functional teams to support preparation, review, and maintenance of CMC regulatory content, ensuring compliance with global regulatory expectations.
Key Responsibilities
• Support preparation and review of Drug Substance manufacturing process descriptions for global regulatory submissions (CTD Module 3.2.S).
• Assist in preparation of variation/supplement documentation associated with DS tech transfer activities.
• Support preparation, review, compilation, and publishing of CMC sections for: o INDs / IMPDs o BLAs / MAAs o Variations / Supplements
• Maintain regulatory trackers for DS-related submissions, commitments, and agency interactions. • Ensure documents comply with CTD format, regulatory guidance, and internal quality standards.
• Assist in ensuring consistency of DS process descriptions across development stages and markets.
• Work closely with Process Development, MSAT, QA, Manufacturing, and Analytical teams to gather regulatory inputs.
• Help maintain consistency of regulatory positions across regions
• Assist senior team members in assessing data adequacy for regulatory submissions and post-approval changes.
• Support responses to health authority queries related to DS manufacturing processes.
• Support regulatory review of: o Process development summaries o Scale-down model qualification data o Process characterisation studies o Process validation o Hold time studies o Resin re-use and lifecycle studies o viral clearance studies
Qualifications & Experience Education
• Master’s degree in Biotechnology, Biochemistry, Pharmacy, Chemical Engineering, or related discipline.