Manager, Regulatory Submission Project Management

Build our future together:

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.

When & where:

• Tokyo, Japan
• Hybrid working model

Discover your role:

• Ensure consistency and standardization across regulatory submissions.
• Provide operational support for PMDA consultations, Clinical Trial Notifications, PCAs, MCNs, and NDAs.
• Coordinate the planning and execution of submission timelines, responsibility matrices, and content plans.
• Guide cross-functional groups to resolve regulatory issues impacting submission quality or timeliness.
• Partner with Regulatory Affairs to meet key regulatory milestones successfully.
• Manage submission deliverables in the regulatory EDMS, including creation of submission objects and binders.
• Review and validate submission documents to ensure compliance with health authority and ICH guidelines.
• You adapt quickly to changing priorities and work effectively with firm deadlines.

This role requires:

• Bachelor’s Degree or equivalent experience.
• At least 6 years of pharmaceutical industry or relevant experience.
• Strong knowledge of PMDA, FDA, EMA, and ICH regulations, guidelines, and specifications.
• Experience with submission processes and systems (e.g., Veeva Vault RIM, docuBridge).
• Proficiency in eCTD and non-eCTD submission formats.
• Project management and timeline management skills for regulatory submissions.
• Expertise in MS Office applications and Adobe Acrobat.