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
