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About the Role
Regeneron is seeking a Senior Director, Regulatory Affairs to support our Japan business. This role involves leading regulatory strategies and submissions across multiple therapeutic areas, collaborating with global teams, and contributing to a science-driven organization focused on developing life-changing medicines.
Responsibilities
- Plan and execute Japan regulatory strategies, including Japan NDA and PMDA consultations.
- Lead NDA, approval, and post-approval change/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 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.
Requirements
- Bachelor's degree in a scientific discipline; Master's degree preferred; Doctor’s degree advantaged.
- Strong experience in Development and Regulatory Strategies roles with demonstrated track record of delivery of Japan NDA.
- People management experience preferred.
- Deep knowledge of Japan clinical development requirements.
- Expertise in Japan submission requirements, regulations, and local standards.
- Business level English fluency.
- Strategic thinking, commercial awareness, strong written and verbal communication skills, and success in global matrix environments.
Skills
- Strategic thinking
- Commercial awareness
- Strong written communication
- Strong verbal communication
Location
- Tokyo, Japan
Work Type
- Hybrid
Experience Level
- Senior Director
Education Level
- Bachelor's degree in a scientific discipline
- Master's degree
- Doctor's degree
Benefits
- Annual bonuses or other incentive plans
- Equity awards
- Pension or retirement benefits
- 401(k) company match
- Health and wellness programs
- Fitness centers
- Insurance benefits (e.g. medical, dental, vision, life and disability)
- Paid time off
- Family support benefits
About the Company
- Regeneron uses science and innovation to develop life-changing medicines for people with serious diseases.
- We are committed to building a workplace with an inclusive culture.
Equal Opportunity
- Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law.
- Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.