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Manager, Regulatory Submission Project Management (RSPM)

Company

Regeneron Pharmaceuticals, Inc

Location

Japan, Japan

Type

Full-time

Are you ready to make a difference in the world of regulatory operations? At Regeneron, we’re seeking a Manager of Regulatory Submission Project Management (RSPM) to lead the strategic planning and execution of regulatory milestones across our therapeutic areas. This is your chance to join a collaborative and innovative team that drives impactful regulatory programs from start to finish. With opportunities to shape global submissions and work alongside cross-functional teams, this role is pivotal in ensuring the success of our regulatory initiatives.

A Typical Day:

  • Facilitate Global Regulatory Sub-team (GRST) meetings, serving as the meeting chair in collaboration with the Regulatory Affairs liaison.
  • Conduct kickoff meetings for major submissions, ensuring alignment and tracking progress with cross-functional teams.
  • Create and manage submission timelines, responsibility matrices, and tables of content (TOCs) to ensure seamless execution of ...

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