Associate Director, Regulatory Affairs

Revolution Medicines • Redwood City, CA

122d • $180,000 - $225,000

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 Associate Director of Regulatory Affairs 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. Demonstrate leadership within the regulatory affairs department and cross-functionally to help develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior concerning risks. Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence. Help drive operational decision making and planning within the department, overseeing workflow, assignments, and staff development with minimal direction. Utilize a comprehensive knowledge of regulations, regulatory authorities' guidance, and industry practices to support organizational objectives. Able to proactively identify risks and devise mitigation strategies. Function as a Regulatory Affairs subject matter expert member of cross-functional teams, including study teams and submission teams. Perform regulatory research to inform business strategy. Assess and communicate risks. Assure that there are no significant interruptions to the business due to regulatory compliance issues. Collaborates across the organization at all levels, across functional groups, and with executive management. Develop regulatory strategies to inform associated budgets, tools and specialized support necessary for efficient operations.

Requirements

• Bachelor's Degree in a relevant field; an advanced degree is desirable.
• Minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience.
• Minimum of 5 years in Regulatory Affairs.
• Experience in the preparation and submission of large, complex regulatory documentation.
• Experience representing Regulatory Affairs on cross-functional teams and presenting to senior management.
• Excellent planning and organizational skills.
• Ability to work simultaneously on multiple projects with tight timelines.
• Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance.

Nice To Haves

• Direct experience with oncology drug development 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

• Independently represent regulatory affairs on cross-functional teams.
• Provide targeted, actionable advice across the clinical development organization.
• Demonstrate leadership within the regulatory affairs department and cross-functionally.
• Plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
• Drive operational decision making and planning within the department.
• Oversee workflow, assignments, and staff development with minimal direction.
• Utilize knowledge of regulations and industry practices to support organizational objectives.
• Identify risks and devise mitigation strategies proactively.
• Function as a Regulatory Affairs subject matter expert on cross-functional teams.
• Perform regulatory research to inform business strategy and assess risks.
• Ensure no significant interruptions to the business due to regulatory compliance issues.
• Collaborate across the organization at all levels and with executive management.
• Develop regulatory strategies to inform associated budgets and necessary support.

Benefits

• Competitive cash compensation
• Robust equity awards
• Strong benefits
• Significant learning and development opportunities

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Bachelor's degree