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:
As a Manager, Regulatory Submission Project Management, your day may include:

• 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 timeliness.
• 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 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.