Senior Manager, Regulatory Affairs at Revolution Medicines

You're a seasoned regulatory affairs professional with at least 10 years of experience and a Bachelor's degree, looking to make a significant impact in the onco

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 at least 10 years of experience and a Bachelor's degree, looking to make a significant impact in the oncology space. Your background includes a strong understanding of US FDA pharmaceutical regulations. **What makes it worth a look...** Revolution Medicines is offering a full-time, hybrid role in Redwood City, California, with a base salary range of $164,000 - $205,000 annually. They are a late-stage clinical oncology company focused on novel targeted therapies. **You might be a good fit if you...** * Have a strong working knowledge of US FDA pharmaceutical regulations and guidance. * Possess previous experience specifically within the oncology field. * Have a proven track record of successfully managing regulatory submissions. * Are comfortable assessing and communicating regulatory risks.

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 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.

• 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.

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

• Excellent written and verbal communication skills.

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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