Cell Therapy Regulatory Affairs Manager
3 days ago
We are seeking a highly skilled Cell Therapy Regulatory Affairs Manager to support the development and successful performance of our CMC regulatory strategy for innovative pipeline products.
Key Responsibilities- Interpret global regulations and guidance to identify risks, providing input for cross-functional product teams.
- Partner with stakeholders to deliver regulatory dossiers and health authority interaction briefing documents, managing and maintaining regulatory dossiers throughout the product development lifecycle.
- Review and compile submission documents and correspondence to ensure high-quality content, organization, clarity, and accuracy.
- Represent CMC regulatory affairs on product teams and in health authority interactions.
- Provide regulatory assessments for manufacturing changes and quality compliance, participating in technical risk assessment exercises.
- Support the development and maintenance of regulatory templates, best practices, and procedures.
- Bachelor's degree in life sciences, advanced degree preferred.
- 8+ years of experience with BS/BA; 6+ years with MS/MA or MBA; 5+ years with PhD.
- Prior experience in cell/gene therapy, in-depth knowledge of global CMC regulations, and understanding of evolving challenges and health authority expectations for cell therapies.
- Experience in IND, IMPD, BLA, MAA filings.
- Estimated annual base salary: $126,000 - $174,000, depending on individualized factors.
- Short-term incentive bonus opportunity
- Equity-based long-term incentive program
- 401(k) plan
- Paid vacation and holidays; paid leaves
- Health benefits including medical, prescription drug, dental, and vision coverage.
AstraZeneca is an equal opportunities employer, committed to building an inclusive team representing diverse backgrounds. We believe that a wide range of perspectives leads to better work and a more successful company. We welcome applications from all qualified candidates, regardless of their characteristics.
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