Senior Manager, Regulatory Affairs
1 week ago
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 Senior Manager of Regulatory Affairs will provide project teams with regulatory advice, manage, and coordinate various Regulatory Affairs activities within and between departments, and obtain and maintain National Health Authority approvals for investigational products. The position may also undertake regulatory intelligence and research supporting company decision-making.
Specifically, you will be responsible for:
- Manage planning, preparation, coordination, and submission of regulatory documents to global National Health Authorities. Such submissions may include Clinical, Preclinical, or CMC content.
- Correspond and collaborate with RevMed colleagues and departments to achieve alignment.
- Function as a Regulatory Affairs 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.
- Collaborates across the organization at all levels, across functional groups, and with executive management.
- Develop regulatory strategies to inform associated budgets, tools, and specialized support necessary for efficient operations.
- Bachelor's Degree in a relevant field and at least 5 years of direct Regulatory experience.
- Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
- Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.
- Proven track record of successful submissions within a regulatory environment.
- Exceptionally strong team player with excellent interpersonal and communication skills.
- Detail-oriented with strong organizational skills and high-quality standards.
- 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.
#LI-Hybrid #LI-SH1
The base pay salary range for this full-time position for candidates working onsite at our headquarters in Redwood City, CA is listed below. The range displayed on each job posting is intended to be the base pay salary range for an individual working onsite in Redwood City and will be adjusted for the local market a candidate is based in. Our base pay salary ranges are determined by role, level, and location. Individual base pay salary is determined by multiple factors, including job-related skills, experience, market dynamics, and relevant education or training.
Please note that base pay salary range 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.
Base Pay Salary Range
$164,000-$205,000 USD
-
Associate Director, Regulatory Affairs
1 week ago
Redwood City, CA, United States REVOLUTION Medicines Full timeRevolution 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...
-
Associate Director, Regulatory Affairs
2 weeks ago
Redwood City, CA, United States REVOLUTION Medicines Full timeRevolution 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...
-
Associate Director, Regulatory Affairs
7 days ago
Redwood City, CA, United States REVOLUTION Medicines Full timeRevolution 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...
-
Director, Regulatory Affairs
2 weeks ago
Redwood City, CA, United States REVOLUTION Medicines Full timeRevolution 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...
-
Director, Regulatory Affairs
2 weeks ago
Redwood City, CA, United States REVOLUTION Medicines Full timeRevolution 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...
-
Redwood City, CA, United States Soleno Full timeAbout Soleno Therapeutics Inc Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA. At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are - it is in our...
-
Redwood City, CA, United States Soleno Full timeAbout Soleno Therapeutics Inc Soleno is a biopharmaceutical company focused on the development and commercialization of novel therapeutics for the treatment of rare diseases based in Redwood City, CA. At Soleno, we are driven by the unique and multi-faceted needs of the PWS community. Like these individuals, resilience is part of who we are - it is in our...
-
Director, Regulatory Affairs Strategy
2 weeks ago
Redwood City, CA, United States Arcellx, Inc. Full timeWho We Are Arcellx isa public, clinical-stage biotechnology company reimagining cell therapy by engineering innovative immunotherapies for patients with cancer and other incurable diseases. We believe that cell therapies are one of the forward pillars of medicine and our mission is to destroy cancer and advance humanity by developing cell therapies that are...
-
Redwood City, CA, United States Codexis Full timeAssociate Director/ Director, CMC Regulatory AffairsDepartment: 58 - Tech Ops Management Employment Type: Full Time Location: Redwood City, CA Compensation: $185,000 - $250,000 / year Description Codexis, a biotech company based in Redwood City, CA, is looking to hire an Associate Director/Director of CMC Regulatory Affairs. Codexis is a leading enzyme...
-
Senior Manager
2 weeks ago
Foster City, CA, United States Mindlance Full timeSr Manager - Medical Affairs (Open to Either NJ Parsippany or Foster City Locations) Virology & / or Oncology background **Do NOT submit candidate: Maneesh Mathur **This role is identical as the other one currently open but is for another Sr Director and can be remote** *They must be local to either site to commute in when needed as the roles will be...
