Regeneron Hiring CMC Regulatory Affairs Manager

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite®, which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center® (RGC) and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

Post : Manager CMC Regulatory Affairs

Job Description
• Contribute to the management of the regulatory submission form process, which involves reviewing documentation submitted to global health authorities to support the release of lots to clinical trials.
• Support cross-functional departments in understanding the current, approved regulatory landscape for all global CTAs.
• Participate in cross-functional meetings to help identify CMC regulatory issues related to submission documentation for clinical trials, ensuring timely communication between IOPS and global development.
• Participate in the development of procedures and systems for enhanced tracking of global regulatory submission packages and approval status.
• Lead meetings and presentations on more complex regulatory issues and participate in creating regulatory justifications.
• Keep management and all stakeholders informed of assessments, overall strategy, and project status.
• Contribute to training programs, metrics, and invoice approvals.
• Act as a submission compliance liaison with other areas of Regulatory Affairs, Regulatory Submission Management, Clinical Drug Supply and Logistics, and Quality to ensure submissions appropriately support the release of IP.
• Manage and lead a team.

Candidate Profile
• BS/BA in Chemistry, Biology, or a related field (advanced degree preferred).
• Minimum of 7–9 years of experience working in the biopharmaceutical manufacturing or related industry, including experience in regulatory or compliance related activities.
• Minimum of 2 years of leadership and/or managerial experience.
• Strong compliance background preferred.
• Experience in program management a plus.
• Ability to build collaboration and teamwork across cross-functional teams.
• Ability to work in an ambiguous environment and produce maximum results with minimum direction and guidance.
• Demonstrated history of building and maintaining positive relationships both internally and externally.
• Strong communication and negotiation skills.
• Open and receptive to change, while continually looking for opportunities to improve processes.
• Strong understanding of quality principles in a regulated manufacturing environment is helpful.

Additional Information
Experience : 7–9 years
Qualification : Chemistry, Biology
Location : Hyderabad, India
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : CMC Regulatory Affairs
End Date : 10th September 2026