Senior Manager, Commercial Regulatory Affairs
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Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
13 hours ago
Vacancies:
1 Vacancy
Job Summary
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin 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 Affairsto 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.
Bachelors 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.
#LI-Hybrid #LI-JC1
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.
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 very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect process and use any personal data that you provide to us in accordance with ourCCPA additional information please contact.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms email phone or text message.
Please note that Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information purchase equipment or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official @ email address.
If you believe youve been contacted by someone impersonating a Revolution Medicines recruiter please report it to so we can share these impersonations with our IT team for tracking and awareness.
Required Experience:
Senior Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
