Regulatory Affairs Manager
6 days ago
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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