Associate Director, Regulatory Science

Revolution Medicines

3d•$177,000 - $221,000

About The Position

The Associate Director of Regulatory Science may represent Regulatory Science on cross-functional teams and provide regulatory advice on clinical development matters. The role requires a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking, as well as the ability to provide clear and concise feedback, facilitate decision-making, and provide effective leadership to ensure successful regulatory outcomes. The role develops, implements, and maintains initiatives, processes, and procedures, recognizing when to consult senior departmental personnel about risks. It plans, prepares, and coordinates regulatory submissions to ensure quality and adherence to timelines; applies knowledge of regulations, health authority guidance, and industry practices to support organizational objectives; identifies risks and mitigation strategies; and performs regulatory research to inform business strategy. The Associate Director serves as a Regulatory Science subject matter expert on cross-functional study and submission teams, assesses and communicates risks, and helps prevent significant business interruptions caused by regulatory compliance issues. Revolution Medicines is a global oncology company focused on discovering, developing, and delivering medicines for patients with RAS-addicted cancers. The company describes its work as grounded in rigorous scientific inquiry and a commitment to serving patients.

Requirements

Bachelor's degree in a relevant field; an advanced degree is desirable.
A minimum of 9 years in the pharmaceutical or biotechnology industry or relevant work experience.
A minimum of 5 years in Regulatory Affairs.
Experience preparing and submitting large, complex regulatory documentation to support health agency review and approval procedures and post-approval activities.
Experience representing Regulatory Science on cross-functional teams.
Excellent communication skills.
Excellent planning and organizational skills, including the 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

Advanced degree.
Experience with EU CTR submissions.
Direct experience with oncology drug development.
Experience with combination studies and multiple expansion cohort, basket, or umbrella master protocols.
Direct experience with FDA expedited programs.

Responsibilities

Represent Regulatory Science on cross-functional teams and provide regulatory advice on clinical development matters.
Develop, implement, and maintain initiatives, processes, and procedures, consulting senior departmental personnel about risks when appropriate.
Plan, prepare, and coordinate regulatory submissions, ensuring high quality and adherence to timelines.
Apply knowledge of regulations, regulatory authority guidance, and industry practices to support organizational objectives.
Identify risks proactively and devise mitigation strategies.
Serve as a Regulatory Science subject matter expert on cross-functional study teams and submission teams.
Conduct regulatory research to inform business strategy and assess and communicate risks.
Help ensure regulatory compliance issues do not cause significant interruptions to the business.
Present to senior management.