Associate Director, Global Regulatory Affairs Cell Therapy

Legend Biotech, Inc.; New Jersey; On-site; USD 168,000 - 221,000; Full time

Job summary

Legend Biotech USA Inc. in Somerset, New Jersey, seeks an Associate Director of Regulatory Affairs to lead global regulatory strategies for our cell therapy programs.

You will represent Regulatory Affairs on cross-functional teams, interact with health authorities, and drive timely, high-quality submissions for INDs, CTAs, and BLAs. The role requires a PharmD or PhD, 5+ years in regulatory affairs, and strong leadership and communication skills.

Qualifications

• PharmD or PhD in science/healthcare required.
• Minimum 5+ years in regulatory affairs for drug development (IND/CTA/BLA/MAA).
• Global regulatory knowledge; biologics/cell therapies preferred.
• Ability to independently lead global regulatory strategies and submissions.

Responsibilities

• Develop innovative global regulatory strategies for Legend pipeline programs.
• Lead IND/CTA/BLA submissions and related supplements/variations to ensure timely submissions.
• Evaluate need for diagnostic/companion diagnostic tests for pipelines as needed.
• Maintain INDs, CTAs, BLAs and ex-US filings as required.
• Interface with FDA and other health authorities for feedback and alignment on strategies.
• Represent Regulatory Affairs in global cross-functional development teams.

Skills

Regulatory strategy

IND/CTA filings

BLA submissions

Team leadership

FDA liaison

Cross-functional collaboration

Cell therapy

Education

PharmD or PhD

Job description

Legend Biotech USA Inc. in Somerset, New Jersey, seeks an Associate Director of Regulatory Affairs to lead global regulatory strategies for our cell therapy programs.

You will represent Regulatory Affairs on cross-functional teams, interact with health authorities, and drive timely, high-quality submissions for INDs, CTAs, and BLAs. The role requires a PharmD or PhD, 5+ years in regulatory affairs, and strong leadership and communication skills.