Manager, CMC Regulatory Affairs

About the role

Regeneron is seeking a Manager, CMC Regulatory Affairs to lead the regulatory submission process for clinical trial product releases. Based in Hyderabad, the role combines oversight of documentation submitted to global health authorities with cross‑functional collaboration to ensure timely lot release for investigations.

Key responsibilities

• Manage the regulatory submission form process, reviewing documentation for global health authority approval to support clinical trial lot release.
• Collaborate with cross‑functional teams, providing guidance on the current approved regulatory landscape for all global CTAs.
• Identify and communicate CMC regulatory issues in submission documentation, ensuring alignment between IOPS and global development.
• Develop procedures and systems for tracking regulatory submission packages and approval status.
• Lead meetings on complex regulatory topics and prepare regulatory justifications.
• Maintain communication with stakeholders, providing updates on assessments, strategy, and project status.
• Act as liaison with Regulatory Affairs, Clinical Drug Supply, Logistics, and Quality to ensure compliance.
• Manage and develop a team of regulatory professionals.

Required profile

• BS/BA in Chemistry, Biology or related field (advanced degree preferred).
• Minimum 7‑9 years experience in biopharmaceutical manufacturing or related industry, including regulatory/compliance activities.
• At least 2 years of leadership or managerial experience.
• Strong compliance background and understanding of quality principles in a regulated manufacturing environment.
• Proven ability to build collaboration across cross‑functional teams and navigate ambiguous environments.
• Excellent communication and negotiation skills.