Revolution Medicines
Temp Director, Regulatory Affairs
Revolution Medicines - San Francisco, California, United States, 94199
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Overview
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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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Read all the information about this opportunity carefully, then use the application button below to send your CV and application.
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.
Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs. Motivate, mentor and develop direct reports to ensure development and performance. Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones. Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success. Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly. 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. Proven success in developing and delivering global regulatory strategies and submissions. Demonstrated success in leading health authority interactions and negotiations. Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies. Strong track record in alliance management, coordinating with external development or commercialization partners. Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership. Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.
Preferred Skills:
An advanced degree is desirable. Experience with dose optimization in oncology. 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 levelDirector Employment type
Employment typeFull-time Job function
Job functionLegal Referrals increase your chances of interviewing at Revolution Medicines by 2x Get notified about new Director of Regulatory Affairs jobs in
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Temp Director, Regulatory Affairs
role at
Revolution Medicines 1 day 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 professionals in a tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
Read all the information about this opportunity carefully, then use the application button below to send your CV and application.
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.
Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs. Motivate, mentor and develop direct reports to ensure development and performance. Ensure late-stage oncology programs are fully resourced and anticipate regulatory needs to deliver on programming milestones. Develop robust global regulatory strategies that reflect competitive intelligence, expert input, and align with corporate goals to ensure global success. Drive consistency in regulatory approach, ensuring lessons learned across programs are applied broadly. 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. Proven success in developing and delivering global regulatory strategies and submissions. Demonstrated success in leading health authority interactions and negotiations. Direct experience in oncology drug development including oversight of large, global Phase 3 and platform studies. Strong track record in alliance management, coordinating with external development or commercialization partners. Skilled at representing Regulatory on cross-functional teams and presenting to senior leadership. Excellent communication, planning, and organizational skills with the ability to manage multiple projects and tight deadlines.
Preferred Skills:
An advanced degree is desirable. Experience with dose optimization in oncology. 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 levelDirector Employment type
Employment typeFull-time Job function
Job functionLegal 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, Contracts and Legal Operations Mountain View, CA $192,000.00-$270,000.00 20 hours ago Redwood City, CA $340,000.00-$390,000.00 1 week ago Director & Senior Legal Counsel, Patents San Jose, CA $207,500.00-$276,700.00 22 hours ago San Jose, CA $259,200.00-$624,000.00 1 week ago San Francisco, CA $120,000.00-$190,000.00 2 weeks ago Director, Competition, Regulatory, and Antitrust Legal San Mateo, CA $271,300.00-$406,900.00 1 week ago Palo Alto, CA $191,510.00-$309,800.00 2 weeks ago Sr. Director, Corporate Affairs & Legal Leadership Communications San Francisco Bay Area $243,100.00-$314,600.00 22 hours ago Executive Director, Regulatory Affairs CMC San Jose, CA $70,000.00-$80,000.00 5 days ago San Francisco Bay Area $60.00-$63.00 2 weeks ago San Francisco, CA $166,360.00-$234,864.00 1 month ago Vice President / Head of Regulatory AffairsDirector, Regulatory Affairs - Job ID: 1702 Palo Alto, CA $225,000.00-$240,000.00 2 weeks ago Director, Assistant General Counsel - Procurement Menlo Park, CA $239,000.00-$357,000.00 2 weeks ago Santa Clara, CA $135,000.00-$185,000.00 1 month ago Redwood City, CA $306,000.00-$350,000.00 3 weeks ago Santa Clara, CA $135,000.00-$185,000.00 1 month ago Senior Director, Associate General Counsel-Head of Patent Litigation San Jose, CA $188,000.00-$323,950.00 2 days ago San Francisco, CA $137,300.00-$251,800.00 20 hours ago San Jose, CA $137,300.00-$251,800.00 19 hours ago San Jose, CA $228,800.00-$419,200.00 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