Senior Director Regulatory Affairs
3 weeks ago
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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