Regulatory Affairs Manager

6 days ago


Redwood City, California, United States Revolution Medicines Full time

Job Summary:


Revolution Medicines is seeking a Senior Manager, Regulatory Affairs to provide regulatory advice and guidance to project teams.


Key Responsibilities:



  • Manage and coordinate Regulatory Affairs activities within and between departments.
  • Obtain and maintain National Health Authority approvals for investigational products.
  • Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities.
  • Correspond and collaborate with RevMed colleagues and departments to achieve alignment.
  • Function as a Regulatory Affairs subject matter expert member of cross-functional teams.
  • Perform regulatory research to inform business strategy and assess and communicate risks.
  • Assure that there are no significant interruptions to the business due to regulatory compliance issues.
  • Collaborate across the organization at all levels, across functional groups, and with executive management.
  • Develop regulatory strategies to inform associated budgets, tools, and specialized support necessary for efficient operations.

Requirements:



  • Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience.
  • Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
  • Proven track record of successful submissions within a regulatory environment.
  • Exceptionally strong team player with excellent interpersonal and communication skills.
  • Detail-oriented with strong organizational skills and high-quality standards.

Preferred Qualifications:



  • Knowledge of EU EMA Pharmaceutical regulations and guidance.
  • Direct experience with IND/NDA filings.


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