Manager, Regulatory Affairs
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Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
16 hours ago
Vacancies:
1 Vacancy
Job Summary
Revolution Medicines is a clinical-stage precision oncology company focused on developing novel targeted therapies to inhibit frontier targets in RAS-addicted cancers. The companys 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 Revolutionariesin 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.
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.
Required Skills Experience and Education:
Bachelors Degree in a relevant field and at least 3 years of direct Regulatory experience.
Strong working knowledge of US FDA Pharmaceutical regulations and guidance.
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.
Preferred Skills:
Knowledge of EU EMA Pharmaceutical regulations and guidance preferred.
Direct experience with IND/NDA filings.
#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 ourCCPA additional information please contact.
Required Experience:
Manager
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
