REVOLUTION Medicines
Associate Director, Regulatory Affairs - Strategy
REVOLUTION Medicines, Redwood City, California, United States, 94061
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The company's R&D pipeline comprises RAS(ON) Inhibitors designed to suppress diverse oncogenic variants of RAS proteins, and RAS Companion Inhibitors for use in combination treatment strategies. As a new member of the Revolution Medicines team, you will join other outstanding professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology. They will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes. Specifically, you will be responsible for:
Research regulatory requirements and identify relevant precedents to develop well-vetted, actionable strategies for assigned programs. Translate strategy into specific activities supporting product development and corporate goals.Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.Establish highly collaborative and effective relationships with colleagues in Clinical Research, Clinical Operations, Regulatory, Medical Writing, and other functions to ensure alignment and team effectiveness.Responsible for maintaining and applying a working knowledge of the dynamic regulatory landscape in oncology and translating this into actionable steps.Manage direct report(s) and provide mentorship to junior professionals.Required Skills, Experience and Education:
Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree is desirable with a minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 4 years in Regulatory Affairs.Direct experience with immuno-oncology drug development and checkpoint inhibitors highly preferred. Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferredDirect experience with FDA expedited programs highly preferred.Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.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 Affairs 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.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.Direct experience with NDA filing highly preferred.
The base salary range for this full-time position is $160,000 - $200,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-SH1
The Opportunity:
The Associate Director of Regulatory Affairs will provide regulatory leadership to clinical development programs in oncology. They will independently represent regulatory affairs on cross-functional teams and provide targeted, actionable advice across the clinical development organization. The candidate must have a thorough understanding of oncology drug development, applicable regulations, and current health authority thinking and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful regulatory outcomes. Specifically, you will be responsible for:
Research regulatory requirements and identify relevant precedents to develop well-vetted, actionable strategies for assigned programs. Translate strategy into specific activities supporting product development and corporate goals.Independently plan, prepare, and coordinate regulatory submissions, ensuring high quality and timeline adherence.Establish highly collaborative and effective relationships with colleagues in Clinical Research, Clinical Operations, Regulatory, Medical Writing, and other functions to ensure alignment and team effectiveness.Responsible for maintaining and applying a working knowledge of the dynamic regulatory landscape in oncology and translating this into actionable steps.Manage direct report(s) and provide mentorship to junior professionals.Required Skills, Experience and Education:
Degree in biological or life sciences, pharmacy, medicine, or related fields. An advanced degree is desirable with a minimum of 7 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 4 years in Regulatory Affairs.Direct experience with immuno-oncology drug development and checkpoint inhibitors highly preferred. Experience with combination studies, multiple expansion cohort, basket, or umbrella master protocols highly preferredDirect experience with FDA expedited programs highly preferred.Demonstrated experience in strategic problem-solving with health agencies and leading internal teams on regulatory strategy.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 Affairs 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.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.Direct experience with NDA filing highly preferred.
The base salary range for this full-time position is $160,000 - $200,000 for candidates based at our headquarters in Redwood City, CA. The range displayed on each job posting is intended to be the minimum and maximum salary for the position in Redwood City and will be adjusted for the local market a candidate is based. Our salary ranges are determined by role, level, and location. Individual pay is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base salary is one part of the overall total rewards program at RevMed, which includes competitive cash compensation, robust equity awards, strong benefits, and significant learning and development opportunities.
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.
Revolution Medicines takes protection and security of personal data very seriously and respects your right to privacy while using our website and when contacting us by email or phone. We will only collect, process and use any personal data that you provide to us in accordance with our CCPA Notice and Privacy Policy. For additional information, please contact privacy@revmed.com.
#LI-Hybrid #LI-SH1