Senior Manager, Regulatory Affairs

Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers.  The company’s R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

The Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage and coordinate various Regulatory Affairs activities and deliverables within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making as well as regulatory project management to support RA deliverables.

• Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.

• Correspond and collaborate with RevMed colleagues and departments to achieve alignment.

• Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams.

• Perform regulatory research to inform business strategy. Assess and communicate risks.

• Assure that there are no significant interruptions to the business due to regulatory compliance issues.

• Collaborates 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.

Required Skills, Experience and Education:

• 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.

• Knowledge of global regulations and guidance preferred.

• Previous experience in oncology.

• Proven track record of successful management of 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 Skills:

• Experience with supporting the preparation and submission of large complex regulatory submissions, including NDA’s.

• Excellent written and verbal communication skills. 

  #LI-Hybrid #LI-JC1

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base pay salary range is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.

Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

Base Pay Salary Range$164,000—$205,000 USD

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