Regulatory Affairs Lead — Cell Therapy Strategy

Legend Biotech US; New Jersey; Hybrid; USD 168,000 - 221,000; Full time

Benefits offered by this job

Medical Insurance

Dental Insurance

Vision Insurance

401(k) with company match

Paid parental leave

Paid time off

Job summary

Legend Biotech US in Somerset, NJ, seeks an Associate Director, Regulatory Affairs to lead global regulatory strategies for our cell therapy portfolio. You will interact with FDA and other health authorities, coordinate IND/CTA/BLA submissions, and drive regulatory strategy across cross-functional teams.

The role requires a PharmD or PhD with 5+ years of regulatory experience in drug development, with emphasis on biologics and cell therapies.

Qualifications

• PharmD or PhD in science/healthcare required.
• Minimum 5+ years in regulatory affairs for drug development with IND/CTA/BLA/MAA experience.
• Strong knowledge of global regulatory requirements for biologics and cell therapies.
• Ability to independently lead global regulatory strategies and teams.

Responsibilities

• Develop and coordinate global regulatory strategies for Legend pipeline programs.
• Lead IND/CTA/BLA submissions and related supplements, ensuring timely approvals.
• Evaluate need for in-vitro diagnostics or companion diagnostics as required.
• Maintain INDs/CTAs and ex-US filings; interface with FDA and health authorities.
• Represent Regulatory Affairs on cross-functional development teams and external collaborations.
• Coach and mentor junior team members.

Skills

Regulatory strategy leadership

IND/CTA/BLA filings

Global regulatory submissions

FDA/health authority liaison

Cross-functional collaboration

Mentoring junior staff

Oncology/cell therapy knowledge

Strategic thinking

Education

PharmD or PhD in science/healthcare

Job description

Legend Biotech US in Somerset, NJ, seeks an Associate Director, Regulatory Affairs to lead global regulatory strategies for our cell therapy portfolio. You will interact with FDA and other health authorities, coordinate IND/CTA/BLA submissions, and drive regulatory strategy across cross-functional teams.

The role requires a PharmD or PhD with 5+ years of regulatory experience in drug development, with emphasis on biologics and cell therapies.