Associate Director, Regulatory Affairs

Revolution Medicines • Redwood City, CA

163d • $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.

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 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 planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
• Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance.
• Experience with EU CTR submissions preferred.

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

• 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.
• 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.
• Collaborate 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.

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