Associate Manager, CMC Regulatory Affairs

About the role

Regeneron, a biotechnology company developing medicines for serious diseases, is looking for an Associate Manager, CMC Regulatory Affairs to join its Regulatory Affairs team supporting the Japan organization. The role works in a hybrid mode in Tokyo and supports regulatory CMC strategy and submissions across therapeutic areas, working with Global Regulatory CMC, CMC Regulatory Science and cross-functional teams.

Key responsibilities

• Support planning, scientific writing and critical review of CTN, J-NDA and eCTD supplement submissions.
• Prepare Japanese application forms and regulatory dossiers for high-quality submissions.
• Support regulatory decision-making with cross-functional teams based on local requirements.
• 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 for investigational product release requests.
• Monitor project timelines to support on-time regulatory submissions.

Required profile

• Bachelor's degree in a scientific discipline; Master's degree preferred.
• 10+ years of regulatory CMC experience, including health authority interactions, major submissions and approvals in Japan.
• Experience supporting CTN, J-NDA, eCTD submissions, PCA, MCN and PMDA responses.
• Knowledge of Japanese regulatory requirements, guidance documents and regulatory resources.
• Experience in agency meetings and regulatory communications.
• 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 across global teams and contribute strategically.

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, pension, health and wellness programs, insurance, paid time off and family support benefits, depending on country and role.