Senior Manager, Regulatory Affairs
$164k/y-$205k/y
Revolution Medicines2 days ago
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OnsiteFull-timeDirector
Summary
Revolution Medicines is seeking a Senior Manager, Regulatory Affairs to join their team in the San Francisco Bay Area. The role involves providing regulatory advice, managing regulatory activities, and obtaining National Health Authority approvals for investigational products.
About the Role
As a Senior Manager of Regulatory Affairs, you will manage the planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. You will collaborate with various departments to ensure alignment, function as a subject matter expert in cross-functional teams, perform regulatory research, and develop regulatory strategies to support efficient operations.
About You
Required:
- Bachelor's Degree in a relevant field and at least 10 years of Regulatory experience.
- Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
- Proven track record of successful management of submissions within a regulatory environment.
- Exceptionally strong team player with excellent interpersonal and communication skills.
Preferred:
- Knowledge of global regulations and guidance.
- Previous experience in oncology.
- Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA’s.
Benefits
- Competitive cash compensation.
- Robust equity awards.
- Strong benefits package including medical, dental, and vision coverage.
- Significant learning and development opportunities.
Revolution Medicines
We are Revolutionaries – passionate in our singular pursuit of discovering, developing and delivering innovative, targeted medicines for patients living with cancer. To deliver on our vision, we work relentlessly in pursuit of cutting-edge therapeutic approaches to some of the toughest cancers. Our current focus is on RAS-addicted cancers, which account for 30 percent of all new human cancer diagnoses.
San Francisco Bay Area