Vice President, Global CMC Regulatory
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Job Location:
Redwood City, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
11 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:
We are seeking an accomplished strategic and execution-oriented leaders Vice President Global CMC Regulatory reporting to SVP of Pharmaceutical Development and Manufacturing (PDM) Regulatory to lead our global chemistry manufacturing and controls (CMC) regulatory strategy and execution across all development programs and commercial assets. This leader will drive regulatory strategy development lead regulatory interactions and provide expertise throughout the product lifecycle from early development to post-approval variations ensuring the timely submission and approval of high-quality CMC regulatory filings to support our companys pipeline and global growth.
The successful candidate will serve as a senior leadership role within Pharmaceutical Development and Manufacturing (PDM) organization overseeing CMC regulatory activities and ensuring alignment with health authority expectations globally (FDA EMA PMDA NMPA etc.). The role requires expertise in small molecule pharmaceutical development and manufacturing an understanding of the oncology development lifecycle and the ability to thrive in a dynamic fast-paced environment.
Responsibilities:
Global CMC Regulatory Strategy
Develop and execute global CMC regulatory strategies in alignment with product development plans for clinical and commercial programs / marketed products.
Provide strategic CMC regulatory leadership to support global filings approvals and post-approval lifecycle management.
Proactively identify and manage CMC regulatory risks anticipate challenges and develop mitigation strategies to support business objectives and ensure global alignment and compliance.
Health Authority Engagement
Serve as the primary CMC regulatory interface with global health authorities including FDA EMA EU National Competent Authorities and PMDA.
Lead and support CMC-related regulatory meetings scientific advice and responses to health authority questions.
Regulatory Submissions & Lifecycle Management
Oversee the preparation review and submission of high-quality CMC sections for NDAs MAAs J-NDAs and global post-approval variations.
Ensure consistency compliance and scientific rigor across global CMC regulatory filings.
Provide strategic oversight for post-approval changes including site changes process improvements and supply chain optimization.
Interpret and apply evolving CMC regulatory requirements and guidance globally.
Cross-Functional Collaboration
Partner closely with Drug Substance Drug Product Analytical Development and QC Manufacturing Supply Chain Quality and Program Management to align regulatory strategy with technical and operational plans.
Act as a regulatory subject matter expert for tech transfer global site registration comparability protocols and control strategy development.
Team Development & Leadership
Build mentor and lead a high-performing global CMC regulatory team fostering accountability development and innovation.
Manage external regulatory consultants and regional partners to ensure consistent global execution and local expertise.
Required Skills Experience and Education:
Advanced degree (PhD PharmD or MS) in Chemistry Pharmaceutical Sciences or related scientific discipline.
Minimum of 18 years of experience in the biotech/pharmaceutical industry with at least 10 years in CMC regulatory affairs and global submission experience.
Demonstrated success leading global CMC regulatory strategies for small-molecule products.
Proven success scaling CMC regulatory function in a public late-stage biotech/pharma company.
Deep understanding of global regulatory frameworks and guidelines (FDA ICH EMA PMDA NMPA etc.).
Strong leadership and collaboration skills with a demonstrated ability to work cross-functionally and influence stakeholders at all levels.
Strong written and verbal communication skills with the ability to clearly articulate regulatory strategy and risk.
Ability to thrive in a fast-paced matrixed and science-driven environment.
Preferred Skills:
Experience with oncology development programs and familiarity with accelerated or expedited pathways.
Experience with Japan-specific CMC regulatory requirements (e.g. consultations GQP/GMP compliance J-NDA format).
Exposure to lifecycle management activities including global variations site changes and supply chain adaptations.
#LI-Hybrid #LI-GL1
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:
Exec
Key Skills
- Change Management
- Financial Services
- Growing Experience
- Managed Care
- Management Experience
- Analysis Skills
- Senior Leadership
- Performance Management
- Process Management
- Leadership Experience
- negotiation
- Analytics
