Manager, Regulatory Affairs

At Regeneron, we are driven by innovation and a commitment to improving lives. As part of our global expansion, we are seeking a dedicated Regulatory Affairs Manager to join our growing regulatory team in Japan. This role offers a unique opportunity to shape the regulatory landscape for biological products and regenerative medicines in Japan, while collaborating with a diverse team of experts locally and globally. If you’re passionate about navigating regulatory processes and making a meaningful impact, we’d love to hear from you.

A Typical Day:

• Lead the preparation, submission, and maintenance of clinical trial applications to PMDA.

• Coordinate and execute health authority meetings, including PMDA consultations and MHLW meetings.

• Manage timely submissions of marketing authorization applications and post-approval changes for assigned projects.

• Ensure compliance with Japan’s regulatory requirements and local standards.

• Collaborate with cross-functional teams, including clinical, commercial, medical, and patient safety colleagues.

• Assist in the development of local labeling and patient information for key programs.

• Support the regulatory review of promotional materials as needed.

This Role May Be For You If:

• You have a Bachelor’s degree in a scientific discipline, with a Master’s degree in Science or Pharmacy being preferred.

• You bring approximately 5 years of experience in regulatory affairs, particularly with J-NDA submissions and approvals in Japan.

• You take pride in your ability to prepare and review documents like J-CTDs and briefing materials for PMDA consultations.

• You are eager to learn about regulatory strategies and drug development across multiple products.

• You have a strategic mindset, strong commercial awareness, and excellent communication skills in English.

• You thrive in a global, matrixed team environment and enjoy fostering collaboration.

• You are familiar with advising on regulatory requirements for clinical trials (advantageous but not mandatory).

To Be Considered:

To excel in this role, you must have a Bachelor’s degree in a relevant scientific field and approximately 5 years of regulatory experience, including expertise in J-NDA submissions and document preparation for PMDA consultations. Candidates with a Master’s degree in Science or Pharmacy and experience advising on clinical trial requirements will be highly regarded. Strong communication skills in English and the ability to work effectively in a global team are essential.

Join us in shaping the future of medicine and making a difference in patients' lives. Apply now to become a part of our inspiring journey.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location.  In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/.  For other countries’ specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together.  For that reason, many of Regeneron’s roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron’s on-site policy and expectations for your role and your location.
 

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, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions.  For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process.  Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.