Senior Director Regulatory Affairs

3 weeks ago


California, United States EPM Scientific Full time

Summary: Our client, a clinical stage biopharmaceutical company based in California, is seeking an experienced and highly motivated, hands-on regulatory affairs leader to join their team. The successful candidate will be responsible for developing and implementing effective regulatory strategies to support the development of innovative cell therapies. Responsibilities: Serve as the primary liaison with company executives and external company partners. Lead interactions with global health authorities. Collaborate cross-functionally with team members. Oversee submissions including IND/CTA, BLA, Orphan drug designations and amendments Provide expert guidance to the company on all Regulatory matters Skills/Requirements: 10 + years of regulatory affairs experience Extensive experience with Biologics Cell Therapy experience Clinical regulatory experience required. Ability to develop comprehensive global regulatory strategy Successful track record working collaboratively across functions Understanding of CMC related functions Oncology experience preferred

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