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Director, Regulatory Affairs - Strategy

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:

The Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology. They will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.

  • Research regulatory requirements and identify relevant precedents to develop well-vetted, actionable strategies for assigned programs. Translate strategy into specific activities supporting product development and corporate goals.

  • Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.

  • Establish highly collaborative and effective relationships with colleagues in Clinical Research, Clinical Operations, Regulatory, Medical Writing, and other functions to ensure alignment and team effectiveness.

  • Responsible for maintaining and applying a working knowledge of the dynamic regulatory landscape in oncology and translating this into actionable steps.

  • Manage direct report(s) and provide mentorship to junior professionals.

 Required Experience, Skills, and Education:

  • Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree is desirable with a minimum of 10 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 6 years in Regulatory Affairs.

  • Direct experience with immuno-oncology drug development and checkpoint inhibitors highly preferred. Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferred

  • Direct experience with FDA expedited programs highly preferred.

  • Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.

  • Experience in the preparation and submission of large, complex regulatory documentation to support health agency review/approval procedures, post approval activities.

  • Experienced in representing Regulatory Affairs on cross functional teams and presenting to senior management. Excellent communicator.

  • Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.

Preferred Skills:

  • Direct experience with oncology drug development highly preferred.

  • Direct experience with FDA interactions and/or other Regulatory Agencies.

  • Direct experience with FDA expedited programs highly desired.

The expected salary range for this role is $195,000 to $245,000. 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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