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 to join our Regulatory Operations team, supporting our Japan business area in a hybrid work mode. In this role, you will drive the planning, execution, and review of regulatory operations activities while collaborating with cross-functional teams and external vendors. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.
- Tokyo, Japan
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Hybrid working model
- Ensure consistency and standardization across regulatory submissions.
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Provide operational support for PMDA consultations, Clinical Trial Notifications, PCAs, MCNs, and NDAs.
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Coordinate the planning and execution of submission timelines, responsibility matrices, and content plans.
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Guide cross-functional groups to resolve regulatory issues impacting submission quality or timeliness.
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Partner with Regulatory Affairs to meet key regulatory milestones successfully.
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Manage submission deliverables in the regulatory EDMS, including creation of submission objects and binders.
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Review and validate submission documents to ensure compliance with health authority and ICH guidelines.
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You adapt quickly to changing priorities and work effectively with firm deadlines.
- Bachelor’s Degree or equivalent experience.
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At least 6 years of pharmaceutical industry or relevant experience.
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Strong knowledge of PMDA, FDA, EMA, and ICH regulations, guidelines, and specifications.
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Experience with submission processes and systems (e.g., Veeva Vault RIM, docuBridge).
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Proficiency in eCTD and non-eCTD submission formats.
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Project management and timeline management skills for regulatory submissions.
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Expertise in MS Office applications and Adobe Acrobat.
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.
