Regeneron Invites Applications for Manager – CMC Regulatory Affairs in Hyderabad: Key Opening for Life Sciences Professionals
Pharm'Up 
Biotechnology pioneer Regeneron is expanding its regulatory operations and seeking a qualified Manager – CMC Regulatory Affairs for its facility in Hyderabad, India. Known for proprietary technologies such as VelociSuite® and genomic discoveries via the Regeneron Genetics Center® (RGC), the company develops innovative antibody therapies and genetic medicines targeting serious global diseases.
Position Summary & Core Scope
The Manager of CMC (Chemistry, Manufacturing, and Controls) Regulatory Affairs will manage global Clinical Trial Application (CTA) documentation, drive cross-functional compliance, and oversee regulatory submission forms required to authorize investigational medicinal product (IMP) lot releases for clinical trials worldwide.
Key Responsibilities
- Submission Management & Lot Release: Direct the review of global regulatory submission forms and CMC documentation to ensure timely clinical lot release authorization from worldwide health authorities.
- Cross-Functional Alignment: Serve as the regulatory compliance liaison connecting Industrial Operations and Product Supply (IOPS), Global Development, Quality, Clinical Drug Supply, and Logistics teams.
- Global CTA Compliance: Guide departments on regional regulatory landscapes, identify CMC risks early in development, and formulate robust regulatory justifications for complex issues.
- Systems & Process Optimization: Design, track, and improve internal workflows and digital tracking systems for global regulatory submission packages and health authority approval statuses.
- People Leadership: Supervise, mentor, and build high-performing regulatory teams while overseeing departmental training initiatives, metrics tracking, and operational budgets.
Role Overview
- Position: Manager – CMC Regulatory Affairs
- Company: Regeneron
- Location: Hyderabad, Telangana, India
- Education: BS/BA or advanced degree in Chemistry, Biology, or related life science disciplines
- Experience: 7 to 9 years in biopharmaceutical manufacturing/regulatory compliance, including at least 2 years in a managerial or leadership capacity
- Functional Domain: CMC Regulatory Affairs / Biopharma Clinical Research
About the Author
