Manager, Regulatory Submission Project Management (RSPM)

We are seeking an experienced and detail-oriented Manager, Regulatory Submission Project Management (RSPM) to join our dynamic team. This pivotal role offers the opportunity to lead the planning, execution, and review of regulatory operations activities, ensuring the successful submission of regulatory documents and data to health authorities. If you thrive in a collaborative environment and are passionate about driving regulatory milestones, this position could be your next career step.

A Typical Day:

• Collaborating with cross-functional teams to create submission timelines and responsibility matrices.
• Guiding teams and resolving issues related to submission documents to maintain quality and timelines.
• Managing submission deliverables and coordinating with Regulatory Publishing and vendors on document status.
• Reviewing submission content plans and validating documents for compliance with health authority guidelines.
• Supporting PMDA consultations, Clinical Trial Notifications, PCAs, MCNs, and NDAs through operational excellence.
• Maintaining submission templates and obtaining literature references to support submissions.
• Ensuring consistency and standardization across regulatory submissions.
• Tracking and managing metadata within the electronic data management system (EDMS).

This Role May Be For You If:

• You have a strong knowledge of Regulatory Agency regulations, guidelines, and specifications (e.g., PMDA, FDA, EMA, and ICH).
• You excel in project management and timeline management for regulatory submissions.
• You enjoy working with submission processes and systems such as Veeva Vault RIM or docuBridge.
• You are adept at eCTD preparation and validation processes.
• You thrive in fast-paced environments and can adapt quickly to changing priorities.
• You have strong proficiency with MS Office applications and Adobe Acrobat.
• You value collaboration and have exceptional attention to detail.
• You are driven by the opportunity to make meaningful contributions to regulatory milestones.

To Be Considered:
To excel in this role, you must have a Bachelor's Degree and at least six years of pharmaceutical industry or relevant experience. Strong knowledge of submission processes, eCTD guidelines, and regulatory tools is essential. Proficiency with systems like Veeva Vault RIM and docuBridge is highly desirable. Native level fluency in Japanese and business level English is required.

This is your chance to be part of a team that drives impactful regulatory submissions while fostering innovation and collaboration. Apply now to make a difference in regulatory excellence!

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.