Revolution Medicines
Temp Director, Regulatory Affairs
Revolution Medicines, San Francisco, California, United States, 94199
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Temp Director, Regulatory Affairs
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Temp Director, Regulatory Affairs
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Revolution Medicines Get AI-powered advice on this job and more exclusive features. 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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.
Deliver sound regulatory strategy to program teams Motivate, mentor and develop direct reports Ensure drug development programs are fully resourced for applicable stages of development Anticipate upcoming work; ensure robust and effective regulatory strategy support. Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.
Required Skills, Experience and Education:
Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles. Demonstrated success in leading regulatory submissions globally Direct experience with oncology drug development. Experienced in representing Regulatory 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:
An advanced degree is desirable. Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred. Prior NDA experience is highly preferred.
This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.
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 the 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 .
Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
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Temp Director, Regulatory Affairs
role at
Revolution Medicines 2 days ago Be among the first 25 applicants Join to apply for the
Temp Director, Regulatory Affairs
role at
Revolution Medicines Get AI-powered advice on this job and more exclusive features. 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 Revolutionaries in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
The Director of Regulatory Affairs is accountable for the delivery of regulatory strategy for designated programs at RevMed. They will support programs and drug development teams and ensure delivery of targeted, pragmatic, well-vetted, consistent and actionable regulatory advice. The Director will support policy and process development within regulatory and cross-functionally to define a consistent RevMed approach to regulatory advice and strategy. The Director must have a thorough understanding of and be highly experienced in oncology drug development, applicable regulations, and current health authority thinking, and have strong leadership and relationship-building ability.
Deliver sound regulatory strategy to program teams Motivate, mentor and develop direct reports Ensure drug development programs are fully resourced for applicable stages of development Anticipate upcoming work; ensure robust and effective regulatory strategy support. Ensure regulatory strategy takes account of competitive developments, expert feedback, and that advice is aligned with company goals and objectives Ensure regulatory advice, policy and decision-making is consistent across programs and that learnings from one program are fully considered in all other programs. Establish highly collaborative and effective relationships with management colleagues in Clinical Research, Clinical Operations, Regulatory Affairs, Medical Writing, Quality and other functions to ensure cross-functional alignment and team effectiveness.
Required Skills, Experience and Education:
Degree in life sciences, pharmacy, medicine, or related fields with a minimum of 12 years in the pharmaceutical/biotech industry or relevant work experience and a minimum of 8 years in Regulatory Affairs including regulatory strategy and leadership roles. Demonstrated success in leading regulatory submissions globally Direct experience with oncology drug development. Experienced in representing Regulatory 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:
An advanced degree is desirable. Experience with combination studies, multiple expansion cohort, basket or umbrella and master protocols highly preferred. Prior NDA experience is highly preferred.
This is a contract position that will be employed through a third-party recruiting agency. The agency will provide the pay range, which will be based on several factors, including job-related skills, experience, market conditions, and relevant education or training.
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 the 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 .
Seniority level
Seniority level Director Employment type
Employment type Full-time Job function
Job function Legal Referrals increase your chances of interviewing at Revolution Medicines by 2x Get notified about new Director of Regulatory Affairs jobs in
San Francisco Bay Area . Director/Senior Director, Regulatory Affairs Strategy
Menlo Park, CA $205,000.00-$275,000.00 2 weeks ago Director, Regulatory Affairs - Job ID: 1702
Executive Director, Regulatory Affairs CMC
Vice President / Head of Regulatory Affairs
San Francisco County, CA $250,000.00-$275,000.00 4 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago San Francisco Bay Area $204,000.00-$255,000.00 2 weeks ago Senior Director, Regulatory Affairs - Job ID: 1668
Director, Regulatory Affairs - Job ID: 1702
Senior Director, Global Regulatory Affairs
Foster City, CA $270,000.00-$285,000.00 1 week ago Associate Director/Director Regulatory Affairs
Foster City, CA $210,000.00-$225,000.00 1 week ago San Francisco Bay Area $180,000.00-$225,000.00 2 weeks ago Associate Director Regulatory Affairs - Global Regulatory Services
Associate Director Regulatory Affairs CMC
Associate Director of Regulatory Affairs
Exec Director, Regulatory Affairs-Combination Products & Devices
San Francisco Bay Area $274,550.00-$390,830.00 2 weeks ago San Francisco, CA $165,000.00-$200,000.00 3 days ago Director, CMC Regulatory Affairs – Biologics
San Mateo, CA $265,000.00-$295,000.00 2 weeks ago Fremont, CA $179,000.00-$377,000.00 1 week ago Associate Director Regulatory Affairs – APAC - Diabetes Care
Alameda, CA $146,700.00-$293,300.00 3 weeks ago We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr