Senior Manager/Associate Director, Regulatory Affairs (Strategy, Hematology Oncology)
Nurix Therapeutics
Senior Manager/Associate Director position leading regulatory strategy for hematology-oncology programs at a clinical-stage biotech company. Responsible for building and executing global regulatory strategies, managing product development applications, and ensuring compliance across investigational and marketing programs.
Responsibilities
- Develop and execute global regulatory strategies for assigned hematology-oncology programs
- Serve as regulatory representative on early and late-phase clinical studies to ensure compliance
- Prepare regulatory submissions including INDs, NDAs, DSURs, and investigator brochures
- Conduct meetings with regulatory authorities and respond to agency inquiries
- Track regulatory deliverables, manage submission timelines, and oversee quality assurance processes
Requirements
- Bachelor's degree in life sciences, chemistry, pharmacy, or related field
- 10+ years regulatory affairs experience in pharmaceutical development
- Demonstrated expertise in US and global regulatory requirements and authority interactions
- Proven experience managing INDs, CTAs, NDAs, and lifecycle regulatory submissions
- Strong knowledge of oncology drug development and hematology-oncology therapeutic area
- Experience leading cross-functional teams and managing regulatory consultants
- Proficiency with regulatory information management systems and submission planning tools
Vacancy posted 24 days ago
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