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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.

The Opportunity:

Revolution Medicines is seeking an Associate Director, Commercial Regulatory Affairs who will be responsible for overseeing the review of advertising, promotional labeling, and medical communication materials across the product portfolio. This position will establish collaborative partnerships with commercial and medical affairs stakeholders to ensure successful and compliant activities and deliverables.

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.

• Represent Commercial Regulatory Affairs on the Promotional Review Committee (PRC), Medical Review Committee (MRC), and in other applicable cross-functional team meetings to assess and mitigate regulatory and compliance risks.
• Develop and communicate regulatory position and drive cross functional alignment in accordance with FDA regulations and Industry Guidelines for the advertising and promotion of prescription drugs, company policy, and business goals and objectives.
• Provide promotional regulatory strategy and prepare submission of advertising and promotional labeling materials to FDA at the time of dissemination (Form FDA 2253) or for advisory comment requests.
• Serve as an assigned contact and maintain a positive relationship with the US FDA Office of Prescription Drug Promotion (OPDP).
• Participate in the development and maintenance of PRC operational objectives, policies, and procedures.
• Maintain current expertise of the US regulatory promotional environment, including the issuance of new regulations/guidance/policies, relevant FDA enforcement actions, and general awareness of industry practices.
• Deliver regulatory compliance training.

Required Skills, Experience and Education:

• Bachelor’s degree in science or other related discipline.
• 6+ years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.
• Strong knowledge of FDA regulations and Industry Guidelines for the advertising and promotion of prescription drugs, and best practices.
• Strong, current understanding of “scientific exchange” and pre-approval discussions; ability to unpack and deploy these concepts in practice.
• Experience working on pre-launch activities and launch promotional campaigns.
• Prior work experience interacting with OPDP and/or APLB reviewers.
• Experience with submission activities of promotional materials to FDA.
• Collaborative and solution-oriented mindset and approach.
• Strong verbal and written communication and influencing skills.
• Exemplary compliance ethics and high concern for standards.
• Strong strategic and analytic thinking and decision-making skills.

Preferred Skills:

• Advanced degree in science or other related discipline.
• 8+ years of relevant promotional regulatory affairs experience in the biotech or pharmaceutical industry for the US market.

The base salary range for this full-time position is $180,000 to $225,000 for candidates working onsite at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the salary for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Please note that base salary 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.