Senior Director, Regulatory Affairs (Oncology)
$248k - $352.5kExelixis Inc
Senior Director leading global regulatory strategies for oncology assets at a biopharmaceutical company. Responsible for health authority interactions, submission preparation, compliance oversight, and team management across early and late-stage development programs.
Responsibilities
- Develop and implement global regulatory strategies aligned with asset and corporate objectives
- Conduct regulatory intelligence and provide risk assessments for development programs
- Lead preparation and submission of regulatory documentation to health authorities
- Review clinical trial materials for regulatory compliance and strategic alignment
- Supervise regulatory affairs team and manage multiple assets across development stages
Requirements
- Bachelor's degree in related discipline plus 15+ years regulatory experience
- OR Master's degree in related discipline plus 13+ years regulatory experience
- OR PhD in related discipline plus 12+ years regulatory experience
- Extensive knowledge of regulatory requirements and industry practices
- Strong team leadership and cross-functional collaboration skills
- Advanced analytical and problem-solving abilities
- Experience with regulatory submissions (INDs, NDAs, BLAs, DSURs)
Vacancy posted 25 days ago
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