Senior Manager, Regulatory Affairs - Oncology & Japan

About the role

Regeneron, a biotechnology company developing medicines for serious diseases, is looking for a Senior Manager Regulatory Strategy Oncology & Japan Affairs to join its Regulatory Affairs team and support its Japan business. The role leads Japan regulatory strategy across several therapeutic areas, works with global regulatory teams and local partners, and follows a hybrid work model.

Key responsibilities

• Plan and execute Japan regulatory strategies and PMDA consultations for assigned programs
• Lead marketing application and post-approval change submissions
• Manage interactions with the PMDA and other Japanese health authorities
• Lead or support clinical trial notification preparation and submission
• Represent Regulatory Affairs in clinical, commercial, medical and patient safety teams
• Support local labeling, patient information and promotional material review
• Partner with local and global leadership to support Regulatory Affairs operations

Required profile

• Bachelor's degree in a scientific discipline; Master's degree preferred
• 10+ years in the pharmaceutical industry and 5+ years of relevant regulatory experience
• Experience managing health authority interactions, major submissions and approvals in Japan
• Experience supporting business start-up activities
• Fluent Japanese and English

Required skills

• Deep knowledge of Japan submission requirements, local regulations and regulatory standards
• Knowledge of clinical trial requirements and ability to resolve local procedural issues
• Ability to ensure compliance with Japan regulatory requirements
• Strategic thinking, commercial awareness and strong written and verbal communication
• Ability to work effectively in a global matrix environment

What we offer

• A competitive 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