Associate Director, Regulatory Science
Revolution Medicines
Summary
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.
Job description
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.
Requirements
- Bachelor's Degree in a relevant field
- 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
- 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
- Equity Awards
- Health Benefits
- Learning & Development
Company overview
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies for RAS-addicted cancers. The company is pioneering a new class of therapeutics that target oncogenic RAS mutations, which are among the most common drivers of human cancers. Revolution Medicines employs a unique approach to drug discovery, leveraging deep insights into RAS biology to develop small molecule inhibitors that can address previously undruggable targets. Their pipeline includes multiple clinical-stage candidates designed to inhibit various RAS pathway mutations, with a particular focus on KRAS G12C and other RAS variants. The company's scientific platform combines structural biology, medicinal chemistry, and computational approaches to design highly selective inhibitors. Revolution Medicines aims to transform cancer treatment by developing therapies that can overcome resistance mechanisms and provide durable clinical benefits for patients with RAS-driven malignancies. Their research represents a significant advancement in the field of targeted cancer therapy, addressing one of the most challenging areas in oncology drug development.