Remote opportunity at
Revolution MedicinesAssociate Director, Regulatory Science
Revolution Medicines operates as a global commercial-stage oncology organization focused on discovering and delivering novel therapeutics for patients battling RAS-addicted cancers through its RAS(ON) tri-complex inhibitor…
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About This Role
Revolution Medicines operates as a global commercial-stage oncology organization focused on discovering and delivering novel therapeutics for patients battling RAS-addicted cancers through its RAS(ON) tri-complex inhibitor platform. The enterprise seeks an Associate Director, Regulatory Science to function as a subject matter expert and represent the regulatory function on cross-functional initiatives. This professional will provide guidance on clinical development matters, formulate and execute submission strategies, and ensure adherence to timelines for…
Job Description
Revolution Medicines operates as a global commercial-stage oncology organization focused on discovering and delivering novel therapeutics for patients battling RAS-addicted cancers through its RAS(ON) tri-complex inhibitor platform. The enterprise seeks an Associate Director, Regulatory Science to function as a subject matter expert and represent the regulatory function on cross-functional initiatives.
This professional will provide guidance on clinical development matters, formulate and execute submission strategies, and ensure adherence to timelines for large and complex regulatory documentation. The role involves conducting regulatory research to inform business strategy, proactively identifying risks with mitigation planning, and ensuring compliance to prevent business interruptions. Candidates must communicate effectively, navigate multiple parallel projects under tight deadlines, and consult senior personnel on risks.
The position offers a base salary ranging from USD 177,000 to 221,000 per year, adjusted according to the local market for the candidate's base location. The comprehensive total rewards program includes competitive cash compensation, equity awards, benefits, and professional development opportunities.
Responsibilities
- Represent regulatory science on cross-functional teams including study and submission teams
- Provide regulatory advice regarding clinical development matters
- Develop, implement, and maintain departmental initiatives, processes, and procedures
- Plan, prepare, and coordinate regulatory submissions while ensuring high quality and timeline adherence
- Utilize regulatory knowledge and industry practices to support organizational objectives
- Proactively identify risks and design mitigation strategies
- Conduct regulatory research to inform business strategy and assess communication risks
- Ensure no significant business interruptions occur due to regulatory compliance issues
Requirements
- Minimum of 9 plus years of experience in the pharmaceutical or biotech industry or relevant work experience
- Minimum of 5 years of experience in Regulatory Affairs
- Experience preparing and submitting large, complex regulatory documentation for health agency review, approval procedures, and post-approval activities
- Experience representing regulatory science on cross-functional teams and presenting to senior management
- Strong working knowledge of US FDA and EU EMA pharmaceutical regulations and guidance
- Excellent communication, planning, and organizational skills with the ability to handle multiple projects simultaneously under tight timelines
Qualifications
- Bachelor's degree in a relevant field
- Advanced degree is desirable
- Experience with EU CTR submissions
- Direct experience with oncology drug development
- Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols
- Direct experience with FDA expedited programs
Core Skills
Benefits
- Competitive cash compensation
- Robust equity awards
- Strong benefits
- Significant learning and development opportunities
Frequently Asked Questions
Answers are based only on the employer’s listing; where it doesn’t say, neither do we.
What is the salary range for the Associate Director, Regulatory Science role?
The base pay salary range is USD 177,000 to 221,000 per year, which is adjusted for the local market where the candidate is based.
What education and experience are required for this position?
Applicants must hold a Bachelor's degree in a relevant field (an advanced degree is desirable) along with at least 9 years of industry experience in pharmaceuticals or biotech, including a minimum of 5 years specifically in Regulatory Affairs.
What specific background is preferred for candidates applying to Revolution Medicines?
Direct experience in oncology drug development, EU CTR submissions, FDA expedited programs, and master protocols such as basket or umbrella studies is highly preferred.
Is this a remote position?
The posting lists the employment type as remote, though base pay is determined by role, level, and location dynamics.
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