Senior Director, Regulatory Affairs

About the role

Regeneron, a biotechnology company developing medicines for serious diseases, is looking for a Senior Director, Regulatory Affairs to join its Regulatory Affairs team supporting the Japan business. The role is hybrid and involves leading regulatory strategies and submissions across multiple therapeutic areas while working with global regulatory teams and cross-functional colleagues.

Key responsibilities

• Plan and execute Japan regulatory strategies, including Japan NDA and PMDA consultations
• Lead NDA, approval, and post-approval change and life-cycle management
• Support management of the Japan Regulatory Affairs function with local and global leadership
• Oversee interactions with Japanese regulatory authorities alongside Japan Regulatory Leads
• Lead or support clinical trial notification submissions to the PMDA
• Represent Regulatory Affairs on multidisciplinary teams across clinical, medical, commercial and patient safety functions
• Develop local labeling, patient information and promotional material reviews
• Build strong partnerships across global matrix teams

Required profile

• Bachelor's degree in a scientific discipline; Master's degree preferred; doctorate advantaged
• Strong experience in Development and Regulatory Strategies roles with a proven track record of delivering Japan NDAs
• People management experience preferred
• Business-level English fluency

Required skills

• Deep knowledge of Japan clinical development requirements
• Expertise in Japan submission requirements, regulations and local standards
• Strategic thinking, commercial awareness and strong written and verbal communication
• Success in global matrix environments

What we offer

• A total rewards package that may include annual bonuses, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, insurance benefits, paid time off and family support benefits
• Reasonable accommodation during recruitment for applicants with known disabilities or chronic illnesses