Legend Biotech
Director, Regulatory Affairs
$168K–$221K
Somerset, New Jersey, United States · Director · Full-time · Posted Aug 18, 2026
- Experience
- A minimum of 7+ years.
- Education
- Pharm D or PhD degree, or equivalent in a science or health care field.
- Visa sponsorship
- Applicants must be authorized to work in the United States; employment eligibility is verified through E-Verify.
About the job
Develops and executes global regulatory strategies for pipeline programs, leads regulatory submissions, and engages health authorities and collaboration partners.
What you'll do
- Lead preparation, submission, and maintenance of INDs, CTAs, BLAs, and related filings and supplements.
- Represent Regulatory Affairs on cross-functional teams and interact with the FDA and other health authorities on development strategies.
- Assess the need for in-vitro diagnostic or companion diagnostic tests and mentor junior team members.
What they ask for
- Pharm D or PhD degree, or equivalent in a science or health care field.
- 7+ years of regulatory affairs experience in drug development, focused on IND/CTA/BLA/MAA filing and approval processes.
- Experience preparing major regulatory submissions, amendments, and supplements in the US and ex-US countries.
- Ability to develop and lead execution of global regulatory strategies.
Nice to have
- Experience in biologics and cell therapies; cell and gene therapy experience is a plus.
- Experience in drug development in multiple myeloma is a plus.
Pay
$168,372 — $220,988 USD (base pay)
Tools
IND, CTA, BLA, MAA, CDx
Model-written summary · the original posting is authoritative