Global Director, Regulatory Affairs - Cell Therapy

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

Benefits offered by this job

Medical/dental/vision insurance

401(k) with company match

Parental leave (8 weeks)

Job summary

Legend Biotech seeks a Director of Regulatory Affairs in Somerset, NJ to independently develop and execute global regulatory strategies for cell therapy assets. You will lead submissions (IND/CTA/BLA), coordinate cross-functional teams, and interact with health authorities to align on development plans.

A PharmD/PhD and 7+ years of experience are required. You will oversee regulatory activities for US and ex-US programs, mentor junior staff, and contribute to strategic decisions in oncology and

Qualifications

• A PharmD or PhD in science or healthcare is required.
• 7+ years of regulatory affairs experience in drug development, IND/CTA/BLA/MAA filings.
• Broad knowledge of global regulatory requirements and biologics/cell therapies.
• Ability to independently lead and execute global regulatory strategies.
• Experience preparing major regulatory submissions in US and international markets.
• Strong organizational and cross-functional collaboration skills.

Responsibilities

• Develop innovative global regulatory strategies for Legend pipeline programs.
• Lead IND/CTA/BLA submissions and related supplements with timely, high-quality filings.
• Assess need for companion diagnostics and oversee diagnostic strategy when required.
• Maintain regulatory filings and manage ex-US filings as needed.
• Interface with FDA and other authorities to align development plans.
• Coach junior team members on regulatory processes across programs.

Skills

Regulatory strategy leadership

IND/CTA/BLA experience

Global submissions

Team leadership

FDA/health authority interaction

Cell therapy knowledge

Oncology experience

Education

PharmD or PhD in science/healthcare

Job description

Legend Biotech seeks a Director of Regulatory Affairs in Somerset, NJ to independently develop and execute global regulatory strategies for cell therapy assets. You will lead submissions (IND/CTA/BLA), coordinate cross-functional teams, and interact with health authorities to align on development plans.

A PharmD/PhD and 7+ years of experience are required. You will oversee regulatory activities for US and ex-US programs, mentor junior staff, and contribute to strategic decisions in oncology and