Neogene Therapeutics
Pushing the Frontier by pioneering a new class of fully personalized T cell therapies to treat cancer
11 - 50
Manager, Regulatory Affairs - CMC
July 13
🏢 In-office - Los Angeles
Neogene Therapeutics
Pushing the Frontier by pioneering a new class of fully personalized T cell therapies to treat cancer
11 - 50
Description
• The Manager CMC Regulatory Affairs is responsible for supporting the development and successful performance of the CMC regulatory strategy for the innovative pipeline of early and late-stage T cell therapies. • Interpret global regulations and guidance to identify risks and provide input for guidance to cross functional product teams. • Partner with cross-functional stakeholders to deliver regulatory dossiers (e.g. CMC component(s) of IND / IMPD / Master Files, amendments, annual reports) and health authority interaction briefing documents. • Represent CMC regulatory affairs on product teams and in health authority interactions. • Provide regulatory assessments for manufacturing changes and quality compliance and participate in technical risk assessment exercises. • Support the development and maintenance of regulatory templates, best practices, and procedures. • Perform other responsibilities.
Requirements
• BA/BS degree in life sciences required, advanced degree preferred (PhD,MS, PharmD). • Experience of 8+ years 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.
Benefits
• 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.
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