Senior Manager, Regulatory Affairs at Revolution Medicines

You're a seasoned Regulatory Affairs professional with a Bachelor's degree and at least five years of direct experience, ideally in oncology drug development.

Work type: hybrid

Location: Redwood City, California, United States

Salary: $164,000 – $205,000/yr

Type: Full-time

Summary

You're a seasoned Regulatory Affairs professional with a Bachelor's degree and at least five years of direct experience, ideally in oncology drug development. **What makes it worth a look...** This full-time, hybrid role is at Revolution Medicines, offering a competitive salary of USD 164,000 - 205,000 per year in Redwood City, California. **You might be a good fit if you...** * Have a strong working knowledge of US FDA Pharmaceutical regulations and guidance. * Possess a proven track record of successful regulatory submissions. * Are familiar with EU EMA Pharmaceutical regulations and guidance. * Have direct experience with FDA expedited programs.

Job Description

Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS-addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress diverse oncogenic variants of RAS proteins. The company’s RAS(ON) inhibitors daraxonrasib (RMC-6236), a RAS(ON) multi-selective inhibitor; elironrasib (RMC-6291), a RAS(ON) G12C-selective inhibitor; zoldonrasib (RMC-9805), a RAS(ON) G12D-selective inhibitor; and RMC-5127, a RAS(ON) G12V-selective inhibitor, are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals 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 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.

Specifically, you will be responsible for:

• 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.

• 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.

• Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.

• 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.

• Direct experience with oncology drug development highly preferred.

• Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred.

• Direct experience with FDA expedited programs highly preferred.

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.

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