Director, Regulatory Affairs

Revolution Medicines • Redwood City, CA

15h • $211,000 - $264,000 • Hybrid

About The Position

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 Revolutionaries 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.

Requirements

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

Nice To Haves

• An advanced degree is desirable
• 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.

Responsibilities

• Provide regulatory leadership to clinical development programs in oncology.
• Independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization.
• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 501-1,000 employees