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Senior Director, Commercial Regulatory Affairs

Revolution Medicines

Redwood City, CA, US
  • Job Type: Full-Time
  • Function: Regulatory Affairs
  • Industry: Biotechnology
  • Post Date: 07/08/2024
  • Website: www.revmed.com
  • Company Address: 700 Saginaw Dr, Redwood City, California 94063, US

About Revolution Medicines

REVOLUTION Medicines discovers and develops new drugs that harness the therapeutic potential of frontier oncology targets on behalf of cancer patients.

Job Description

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 a Director, Commercial Regulatory, who will, as part of a cross-functional team, lead development of processes, policies, and systems supporting commercial readiness; establish collaborative partnerships with commercial and medical affairs stakeholders to ensure successful and compliant activities and deliverables; train and guide the company on regulatory expectations and requirements at different phases; review materials to ensure compliance.

  • Establish the commercial regulatory function at Revolution Medicines.

  • Lead and participate on cross-functional teams to assess and mitigate regulatory and compliance risks related to commercialization of drug products.

  • Collaborate on or lead new processes and review systems to support commercialization (e.g., Standard Operating Procedures, Veeva PromoMats, Veeva MedComms).

  • Collaborate with relevant commercial and medical stakeholders to ensure business objectives are achieved in a compliant manner.

  • Train the company at all levels on regulatory expectations and requirements at different phases of the product lifecycle, including pre-approval discussions.

  • Serve as an assigned contact and maintain a positive relationship with the US FDA Office of Prescription Drug Promotion (OPDP).

  • Provide promotional regulatory strategy and prepare submission of materials at the time of dissemination (Form FDA 2253) or for advisory comment requests.

  • Ensure the company is launch-ready and regulatory is appropriately resourced to ensure success. 

Required Skills, Experience and Education:

  • Bachelor’s degree in science or equivalent experience.

  • 13+ years’ experience in promotional regulatory affairs (drugs).

  • Strong knowledge of FDA promotional regulations, guidance, best practices, and their evolution.

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

  • Confident in interactions with commercial and medical affairs leaders.

  •  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 analytical thinking and decision-making skills.

The expected salary range for this role is $235,000 to $281,000. An individual’s position within the range may be influenced by multiple factors, including skills and experience in role, overall performance, individual impact and contributions, tenure, and market dynamics. 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.

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 our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.

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