Regulatory CMC Director (Cell & Gene Therapy)
$186.23k - $279.35kAstraZeneca
AstraZeneca seeks a Regulatory CMC Director to lead global chemistry, manufacturing, and controls strategy for cell and gene therapy programs across development stages. The role combines strategic oversight of regulatory pathways, dossier management, health authority engagement, and team leadership to accelerate approvals.
Responsibilities
- Develop and implement global CMC regulatory strategies for cell and gene therapy programs
- Lead CMC components of regulatory submissions including INDs, IMPDs, BLAs, and lifecycle amendments
- Provide regulatory intelligence and risk assessments for manufacturing changes and quality compliance
- Represent CMC regulatory affairs in health authority interactions and product team meetings
- Build and mentor high-functioning teams while supporting hiring and workflow management
Requirements
- Master's or higher degree in life sciences (PhD or PharmD preferred)
- 10+ years regulatory experience with bachelor's degree, or 8+ with master's, or 6+ with PhD
- Prior experience in cell and gene therapy regulatory strategy
- Deep knowledge of global CMC regulations and health authority expectations for cell therapies
- Track record with IND, IMPD, BLA, and MAA filings
- Strong cross-functional leadership and team-building capabilities
- Ability to manage multiple complex programs with incomplete information
Vacancy posted 12 days ago
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