Manager, Regulatory Submission Project Management

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 Manager Regulatory Submission Project Management Japan to join our Regulatory Operations team, supporting our Japan regulatory business area in a hybrid work model. In this role, you will drive timely, compliant regulatory submissions while collaborating with Regulatory Publishing, vendors, and cross-functional teams. 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: Hybrid
Discover your role:
• Ensure consistency and standardization across regulatory submissions.
• Support PMDA consultations, Clinical Trial Notifications, PCAs, MCNs, and NDAs.
• Track submission deliverables in Veeva Vault RIM through submission objects and metadata.
• Manage submission readiness with Regulatory Publishing and external vendors.
• Support eCTD preparation within defined business timelines.
• Review submission content plans for compliance with health authority and ICH guidelines.
• Guide teams on document uploads and submission-related issue resolution.
• You thrive in a fast-paced environment with changing priorities.
This role requires:
• Bachelor’s degree or equivalent experience.
• 7+ years of pharmaceutical industry or related experience.
• Fluency in Japanese and proficiency in English.
• Strong knowledge of PMDA, MHLW, ICH, and applicable regulatory requirements.
• Experience with submission processes and systems, including Veeva Vault RIM and docuBridge.
• Strong eCTD knowledge and experience.
• Experience with Microsoft Office applications and Adobe Acrobat.
• Ability to manage firm deadlines and adapt quickly to changing priorities.
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.