Director, Regulatory Affairs (Global Filing Lead)
Revolution Medicines
Revolution Medicines seeks a Director of Regulatory Affairs to lead global regulatory filings for late-stage oncology programs. This role oversees end-to-end NDA/MAA preparation and submission, coordinating cross-functional teams and managing interactions with health authorities across multiple regions.
Responsibilities
- Drive preparation and execution of global regulatory filings for late-stage oncology programs in EU, UK, Japan and internationally
- Develop and maintain integrated filing plans including timelines, deliverables, and critical path activities
- Lead cross-functional MAA kickoff and coordinate modular dossier sub-teams across clinical, CMC, and quality functions
- Manage health authority meetings, interactions, and coordinate team preparation and query responses
- Identify, mitigate, and report risks to filing timelines and regulatory outcomes to senior management
Requirements
- Life sciences, pharmacy, medicine degree or related field
- Minimum 12 years pharmaceutical or biotech industry experience
- Minimum 8 years regulatory affairs experience including strategy role
- Proven track record executing global NDA/MAA filings from preparation through approval
- Experience with expedited regulatory pathways and programs
- Demonstrated ability to lead health authority interactions and negotiations
- Strong leadership and cross-functional team management capabilities
Vacancy posted 5 days ago
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