Manager, Regulatory Submission Project Management

Regeneron Pharmaceuticals

Full-time other-general
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Location
Minato-Ku, Japan, Japan
Posted
July 15, 2026

Job Description

**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 ti...