Lead CMC Regulatory Affairs for Gene Therapy Programs (Durham)
Full-time
Atsena
Atsena seeks an Associate Director/Director, CMC Regulatory Affairs to lead global regulatory strategy for gene therapy programs from early research to commercialization. The role interfaces with process development, analytical development, manufacturing, and quality to ensure regulatory readiness.
The incumbent will lead CMC sections of INDs/CTAs, BLA/MAA submissions, and annual updates, while coordinating agency interactions with FDA and EMA.
#J-18808-LjbffrVacancy posted 6 hours ago
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