Senior Manager, Commercial Regulatory Affairs at Revolution Medicines

Ideal for a Senior Manager with a Bachelor's Degree and 10 years of relevant experience, including 5-7 years in US promotional regulatory affairs within the bio

Work type: hybrid

Location: Redwood City, California, United States

Salary: $164,000 – $205,000/yr

Type: Full-time

Summary

Ideal for a Senior Manager with a Bachelor's Degree and 10 years of relevant experience, including 5-7 years in US promotional regulatory affairs within the biotech or pharmaceutical industry. **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 USD 164,000 - 205,000 per year. **You might be a good fit if you...** * Serve as a primary or secondary regulatory advertising and promotion reviewer. * Manage regulatory submissions of promotional materials like FDA Form 2253. * Interpret evolving FDA regulatory requirements and enforcement trends. * Train and advise cross-functional teams on commercial regulatory compliance and MLR processes.

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:

Revolution Medicines is seeking a Senior Manager, Commercial Regulatory Affairs to partner closely with the cross-functional teams to ensure that all promotional and medical communication strategies are compliant with applicable regulations, industry standards, and internal policies. This role will help enable successful product commercialization while upholding regulatory integrity and scientific accuracy.

As part of the Regulatory Affairs function, the Senior Manager will work under supervision to provide strategic regulatory advice on advertising/promotion and medical materials to the US organization for assigned products in accordance with business goals and objectives, FDA regulations/guidances, pharma guidelines, and company policy.

The position can be based at our Redwood City, CA site in a hybrid work schedule (preferred) or remote-based with quarterly and as needed travel.

Required Skills, Experience and Education:

• Serves as a primary or secondary regulatory advertising and promotion reviewer for assigned products on MLR teams with oversight.

• Manage regulatory submissions of promotional materials as required (e.g., FDA Form 2253) and interact with health authority stakeholders when applicable.

• Interpret evolving regulatory requirements and enforcement trends to proactively guide commercial strategy and risk assessments.

• Train and advise cross-functional teams on commercial regulatory compliance, MLR process and best practices.

• Monitors US regulatory promotional environment by reviewing regulatory promotional guidelines, untitled and warning letters to pharmaceutical/biotech companies published by OPDP or APLB, and by attendance of major FDLI, DIA and other industry meetings.

• Ensures that changes in US Prescribing Information are reflected in current promotion and advertising.

• Participate in the development and maintenance of MLR operational objectives, policies, and procedures.

• Bachelor's Degree in a relevant field with 10 years relevant experience.

• 5-7 years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.

• Strong understanding of FDA regulatory requirements governing promotional activities and experience managing promotional submissions and reviews.

• Strong, current understanding of scientific exchange and pre-approval discussions; ability to unpack and deploy these concepts in practice.

• Track record of influencing cross-functional decisions and operating with sound regulatory judgment.

• Excellent communication skills and ability to work collaboratively across teams.

• Collaborative and solution-oriented mindset and approach.

• Exemplary compliance ethics and high concern for standards.

• Advanced degree in a relevant field.

• Experience in oncology therapeutic areas.

• Experience with product launches.

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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