Global Director, Regulatory Affairs - Cell Therapy
BioSpace
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Job summary
Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory Affairs to drive global regulatory strategies for its cell therapy portfolio. You will lead cross‑functional teams, coordinate IND/CTA/BLA submissions, and interact with health authorities to ensure timely, high‑quality filings.
The role requires a PharmD or PhD with 7+ years in regulatory affairs, strong leadership, and deep knowledge of biologics and CDx development.
Qualifications
- PharmD or PhD in science/healthcare required.
- 7+ years regulatory affairs in drug development with IND/CTA/BLA/MAA experience.
- Global regulatory knowledge; biologics and cell therapies preferred.
- Independent in formulating and leading global regulatory strategies and submissions.
- Experience preparing major regulatory submissions in US and ex-US.
Responsibilities
- Develop and coordinate global regulatory strategies and submissions.
- Represent Regulatory Affairs on global cross‑functional teams.
- Oversee submissions for INDs, CTAs, and BLAs and related supplements.
- Interface with the FDA and other health authorities for feedback and alignment.
- Lead collaborations with partners and external stakeholders.
- Mentor junior team members and guide project teams.
Skills
Education
Job description
Legend Biotech, based in Somerset, NJ, seeks a Director of Regulatory Affairs to drive global regulatory strategies for its cell therapy portfolio. You will lead cross‑functional teams, coordinate IND/CTA/BLA submissions, and interact with health authorities to ensure timely, high‑quality filings.
The role requires a PharmD or PhD with 7+ years in regulatory affairs, strong leadership, and deep knowledge of biologics and CDx development.
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