Director, Regulatory Affairs

Revolution Medicines • Redwood City, CA

22h • Hybrid

About The Position

The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.

Requirements

• Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles.
• Demonstrated success in leading regulatory submissions globally.
• Direct experience with oncology drug development.
• Experienced in representing Regulatory 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.
• Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred.
• Prior NDA experience is highly preferred.

Responsibilities

• Deliver sound regulatory strategy to program teams.
• Motivate, mentor and develop direct reports.
• Ensure drug development programs are fully resourced for applicable stages of development.
• Anticipate upcoming work; ensure robust and effective regulatory strategy support.
• Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives.
• Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs.
• Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.

What This Job Offers

• Job Type: Full-time
• Career Level: Director