Director, Regulatory Affairs Redwood City, California, United States
Revolution Medicines, Redwood City, CA, United States
Revolution Medicines is a late-stage clinical oncology company developing novel targeted therapies for patients with RAS‑addicted cancers. The company’s R&D pipeline comprises RAS(ON) inhibitors designed to suppress various oncogenic variants of RAS proteins. Its RAS(ON) inhibitors — daraxonrasib (RMC‑6236), elironrasib (RMC‑6291), zoldonrasib (RMC‑9805), and RMC‑5127 — are currently in clinical development. As a new member of the Revolution Medicines team, you will join other outstanding professionals in tireless commitment to patients with cancers harboring mutations in the RAS signaling pathway.
The Opportunity:
Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.
Anticipate regulatory needs to deliver on program milestones.
Develop robust global regulatory strategies that reflect global marketing application filing strategies, expert input, and align with corporate goals to ensure global success.
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, working independently.
Previous experience with NDA and/or global marketing application filings.
Previous experience with global ODD annual reports.
Demonstrated success in leading health authority interactions and negotiations.
Direct experience in oncology drug development including oversight of large, global Phase 3 studies.
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.
Base Pay Salary Range
$211,000 - $264,000 USD
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 while using our website and when contacting us by phone or email. 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.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official
@revmed.com
email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to
careers@revmed.com
so we can share these impersonations with our IT team for tracking and awareness.
#J-18808-Ljbffr
The Opportunity:
Provide clear, effective regulatory strategy as the Regulatory Study Lead for global oncology programs.
Anticipate regulatory needs to deliver on program milestones.
Develop robust global regulatory strategies that reflect global marketing application filing strategies, expert input, and align with corporate goals to ensure global success.
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, working independently.
Previous experience with NDA and/or global marketing application filings.
Previous experience with global ODD annual reports.
Demonstrated success in leading health authority interactions and negotiations.
Direct experience in oncology drug development including oversight of large, global Phase 3 studies.
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.
Base Pay Salary Range
$211,000 - $264,000 USD
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 while using our website and when contacting us by phone or email. 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.
We are aware of recent recruitment scams in which individuals or organizations falsely represent themselves as being affiliated with Revolution Medicines. These scams may appear as false job advertisements or unsolicited contacts through communication or chat platforms, email, phone, or text message. Revolution Medicines does not extend unsolicited employment offers and will never ask candidates to provide financial information, purchase equipment, or pay fees as part of the hiring process. All legitimate communication from Revolution Medicines will come from an official
@revmed.com
email address. If you believe you’ve been contacted by someone impersonating a Revolution Medicines recruiter, please report it to
careers@revmed.com
so we can share these impersonations with our IT team for tracking and awareness.
#J-18808-Ljbffr