Senior Manager, Commercial Regulatory Affairs

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.

Requirements

• 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.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities