[Hiring] Associate Director, Regulatory Science @Revolution Medicines

Role Description

The Associate Director of Regulatory Science may represent regulatory science on cross-functional teams and provide regulatory advice on clinical development matters. The candidate should have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes.

• Develop, implement, and maintain initiatives, processes, and procedures with a recognition of when to consult departmental senior personnel concerning risks.
• Plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.
• 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 Science 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.

Qualifications

• Bachelor's Degree in a relevant field; an advanced degree is desirable.
• Minimum of 9+ 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 Science 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.
• Strong working knowledge of US FDA and EU EMA Pharmaceutical regulations and guidance.
• Experience with EU CTR submissions preferred.

Requirements

• 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.

Benefits

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

Company Description

Revolution Medicines is a global, commercial-state oncology company dedicated to discovering, developing and delivering innovative medicines for patients with RAS-addicted cancers. Leveraging its differentiated RAS(ON) tri-complex inhibitor platform, the company is advancing a broad, integrated portfolio of oral RAS(ON) inhibitors designed to directly target the active, cancer-driving state of RAS.

Founded on rigorous scientific inquiry and a willingness to challenge long-held assumptions, Revolution Medicines is committed to changing the trajectory of disease for patients with RAS-addicted cancers worldwide.

Our people are united by a shared way of working: follow the science, challenge assumptions, act with urgency and hold ourselves to a high standard of rigor—all in service of patients.