Senior Director, CMC Global Regulatory Affairs - Morrisville

Only for registered members Morrisville, United States

2 weeks ago

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Job Summary

The Senior Director, CMC Global Regulatory Affairs is responsible for leading all regulatory CMC development, registration, and compliance activities from early development through commercialization.

Responsibilities

  • Lead development of CMC and device regulatory submission strategies by working closely with colleagues and cross-functional project teams.
  • Assess and communicate global CMC and device regulatory filing requirements to ensure all development activities comply with applicable regulations and guidelines.

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