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:
This Role May Be For You If:
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.