Are you ready to make a difference in the world of regulatory operations? At Regeneron, we’re seeking a Manager of Regulatory Submission Project Management (RSPM) to lead the strategic planning and execution of regulatory milestones across our therapeutic areas. This is your chance to join a collaborative and innovative team that drives impactful regulatory programs from start to finish. With opportunities to shape global submissions and work alongside cross-functional teams, this role is pivotal in ensuring the success of our regulatory initiatives.

A Typical Day:

Facilitate Global Regulatory Sub-team (GRST) meetings, serving as the meeting chair in collaboration with the Regulatory Affairs liaison.Conduct kickoff meetings for major submissions, ensuring alignment and tracking progress with cross-functional teams.Create and manage submission timelines, responsibility matrices, and tables of content (TOCs) to ensure seamless execution of regulatory deliverables.Partner with Regulatory Affairs to drive program teams toward achieving critical milestones like PMDA consultations, Clinical Trial Notifications, and marketing authorization applications (MAAs).Monitor submission deliverables, coordinate with Regulatory Publishing and vendors, and ensure timely submission of regulatory documents.Identify and resolve potential issues that could impact submission timelines, fostering consensus and proactive solutions within the team.Draft and maintain submission templates, cover letters, and routine submission documentation as needed.Support postmarketing regulatory activities, including amendments, annual reports, and Investigator Brochure (IB) updates.

This Role May Be For You If:

You thrive in a dynamic environment and excel at managing multiple priorities with firm deadlines.You enjoy collaborating with cross-functional teams to achieve shared goals and regulatory success.You have a meticulous eye for detail and a proactive approach to identifying and solving challenges.You’re passionate about regulatory operations and have a strong understanding of submission processes, tools, and global agency guidelines.You are proficient in Microsoft Project and have experience with electronic document management systems like SharePoint.You value structured communication and can effectively guide teams to meet milestones and resolve issues.

To Be Considered:

Candidates must have a Bachelor’s degree and at least 6+ years of industry and/or relevant experience. Strong knowledge of applicable regulatory agency regulations (e.g., PMDA, FDA, EMA, ICH) is essential, as is expertise in submission processes and systems, including eCTD. Proficiency in Microsoft Office applications and Adobe Acrobat is required, while project management skills and familiarity with electronic document management systems are preferred.

Join us in shaping the future of regulatory submissions. Apply today to become a part of a team that values innovation, collaboration, and excellence in regulatory operations!

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.