Manager, Regulatory Submission Project Management (RSPM)

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:**

+ Collaborating with cross-functional teams to create submission timelines and responsibility matrices.
+ Guiding teams and resolving issues related to submission documents to maintain quality and timelines.
+ Managing submission deliverables and coordinating with Regulatory Publishing and vendors on document status.
+ Reviewing submission content plans and validating documents for compliance with health authority guidelines.
+ Supporting PMDA consultati...