Manager, CMC Regulatory Affairs

About the role

Regeneron, a biotechnology company developing medicines for serious diseases, is looking for a Manager, CMC Regulatory Affairs to join its Regulatory Affairs team supporting the Japan organization. The role is hybrid and involves leading regulatory CMC activities across therapeutic areas while working with Global Regulatory CMC, CMC Regulatory Science and cross-functional teams.

Key responsibilities

• Lead planning, scientific writing and critical review of CTN, J-NDA and eCTD supplement submissions
• Prepare Japanese application forms and support high-quality regulatory dossiers
• Drive regulatory decisions based on requirements across cross-functional teams
• Act as local liaison with the PMDA for CMC submissions and information requests
• Assess CMC change controls against regulatory filings to maintain compliance
• Review manufacturing processes and specifications against approved filings
• Participate in agency meetings and communicate regulatory positions and feedback

Required profile

• Bachelor's degree in a scientific discipline; Master's degree preferred
• 15+ years of regulatory CMC experience, including health authority interactions, major submissions and approvals in Japan
• Experience leading CTN, J-NDA, eCTD submissions, PCA, MCN and PMDA responses
• Deep knowledge of Japanese regulatory requirements, guidance documents and resources
• Experience managing submission timelines and delivering filings on schedule
• Ability to obtain and maintain Foreign Manufacturing Accreditation or Foreign Manufacture Registration
• High fluency in Japanese and English

Required skills

• Strong biopharmaceutical and regulatory CMC background
• Ability to interpret regulations, communicate effectively and think strategically
• Proven collaboration across diverse teams

The company states that many roles require on-site performance and that background checks may be carried out. It also describes a total rewards package that may include bonuses, equity awards, pension or retirement benefits, health and wellness programs, insurance and paid time off, depending on country and role.