Senior Manager, Commercial Regulatory Affairs
Scorpion Therapeutics, Redwood City, CA, United States
Overview
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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity
Senior Manager, Commercial Regulatory Affairs to partner closely with 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. Responsibilities
Serve 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.
Monitor 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.
Ensure 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.
Qualifications
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.
Preferred Skills
Advanced degree in a relevant field.
Experience in oncology therapeutic areas.
Experience with product launches.
Compensation and Benefits
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $164,000 — $205,000 USD. The range is intended as the base pay salary range for an individual working onsite in Redwood City and may be adjusted for the local market. Base pay is one component of the total rewards program, which includes competitive cash compensation, equity awards, benefits, and learning 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. Revolution Medicines takes protection and security of personal data seriously and respects your right to privacy when using our website and contacting us. We will only collect, process, and use personal data in accordance with our privacy notices and policy. For additional information, please contact privacy@revmed.com.
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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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway. The Opportunity
Senior Manager, Commercial Regulatory Affairs to partner closely with 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. Responsibilities
Serve 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.
Monitor 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.
Ensure 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.
Qualifications
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.
Preferred Skills
Advanced degree in a relevant field.
Experience in oncology therapeutic areas.
Experience with product launches.
Compensation and Benefits
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is $164,000 — $205,000 USD. The range is intended as the base pay salary range for an individual working onsite in Redwood City and may be adjusted for the local market. Base pay is one component of the total rewards program, which includes competitive cash compensation, equity awards, benefits, and learning 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. Revolution Medicines takes protection and security of personal data seriously and respects your right to privacy when using our website and contacting us. We will only collect, process, and use personal data in accordance with our privacy notices and policy. For additional information, please contact privacy@revmed.com.
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