Legend Biotech
Associate Director, Regulatory Affairs
$168K–$221K
Somerset, New Jersey, United States · Director · Full-time · Posted Oct 5, 2026
- Experience
- Minimum of 5+ 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.
About the job
Develops and executes global regulatory strategies for pipeline programs, leads regulatory submissions, and represents Regulatory Affairs in cross-functional teams and interactions with health authorities.
What you'll do
- Lead preparation, submission, and maintenance of INDs, CTAs, BLAs, and related filings, supplements, and variations.
- Engage the FDA and other health authorities and represent Regulatory Affairs on global development teams and external collaborations.
- Assess diagnostic development needs, review promotional materials, and coach junior team members.
What they ask for
- Pharm D, PhD, or equivalent in a science or health care field.
- Minimum 5+ 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; good understanding of CDx development.
Nice to have
- Experience with biologics and cell therapies; experience in cell and gene therapy.
- Experience in drug development in multiple myeloma.
Pay
$168,372 — $220,988 USD (base pay)
Tools
INDs, CTAs, BLAs, MAA, CDx, FDA, SOP
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