Senior Regulatory Affairs Director - Oncology Cell & Gene Therapy
AstraZeneca
Senior Director leading global regulatory strategy for complex cell and gene therapy oncology products through approval and commercialization. Reports to senior leadership while providing team mentorship and serving as key interface with health authorities and cross-functional product teams.
Responsibilities
- Develop and implement global regulatory strategy for complex CGT products from current stage through BLA submission
- Lead Global Regulatory Strategy Team and provide coaching and performance feedback to team members
- Guide regulatory strategy for health authority meetings, information requests, BLA development, and expedited pathway designations
- Represent Regulatory Affairs on Global Product Teams and deliver all regulatory milestones and compliance activities
- Partner with marketing and regional staff to influence regulatory guidance and support product maintenance
Requirements
- Advanced degree in science field plus 7-10 years regulatory experience
- Demonstrated success in cell and/or gene therapy regulatory strategy
- Deep knowledge of global regulatory science and drug development processes
- Experience with multiple myeloma product development
- Proven track record leading regulatory and cross-functional teams
- Previous experience conducting major health authority interactions
- Excellent written, oral, and presentation skills
Vacancy posted 3 days ago
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