Senior Director, Regulatory Affairs

Build our future together:

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Senior Director, Regulatory Affairs to join our Regulatory Affairs team, supporting our Japan business in a hybrid work mode. In this role, you will lead regulatory strategies and submissions across multiple therapeutic areas while collaborating with global regulatory teams and cross-functional colleagues. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

When & where:

• Location: Tokyo, Japan
• Work model/flexibility: Hybrid

Discover your role:

• 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.

This role requires:

• 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

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We are committed to building a workplace with an inclusive culture. 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.

Where necessary, we disclose salary ranges for roles in all countries in which we operate.  The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits.  Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: 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, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other locations, additional information will be provided during the recruitment process.  If you have any questions, please speak with your recruiter. 

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.