Associate Director, Regulatory Science

revolutionmedicines; United States; On-site; USD 177,000 - 221,000; Full time

Job summary

Revolution Medicines in the United States is seeking an Associate Director of Regulatory Science to lead regulatory strategy for oncology programs. You will provide regulatory guidance on clinical development, coordinate cross-functional teams, and drive decision-making to ensure timely approvals.

This onsite role at our Redwood City, CA headquarters requires a deep understanding of US FDA and EU EMA processes, with 9+ years in pharma/biotech and 5+ years in Regulatory Affairs.

Qualifications

• 9+ years in pharma/biotech with 5+ years in Regulatory Affairs.
• Experience preparing large, complex regulatory submissions.
• Strong cross-functional representation and senior management presentation.
• Deep knowledge of US FDA and EU EMA regulations; EU CTR experience preferred.

Responsibilities

• Plan, prepare, and coordinate regulatory submissions with timelines.
• Assess regulatory risks and communicate mitigation strategies.
• Serve as Regulatory Science SME on cross-functional teams.
• Ensure no significant business interruptions due to regulatory issues.

Skills

Regulatory Affairs

Cross-functional leadership

Regulatory submissions

Education

Bachelor's degree in a relevant field

Job 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.

The Opportunity:

• 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.

Required Skills, Experience and Education:

• Bachelor's Degree in a relevant field, an advanced degree is desirable, with a minimum of 9+ years in the pharmaceutical/biotech industry or relevant work experience and a 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.

Preferred Skills:

• 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.

The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.

Base Pay Salary Range

$177,000 - $221,000 USD

Revolution Medicines is an equal opportunity employer and prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital status, medical condition, and veteran status.