Regulatory Affairs Director: Global Cell Therapy

Socket.dev; New Jersey; On-site; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

401(k) with company match

Job summary

Legend Biotech seeks a Director of Regulatory Affairs to independently develop and coordinate global regulatory strategies for its cell therapy programs. Based in Somerset, NJ, the role will interact with health authorities and oversee regulatory filings to ensure timely submissions.

The candidate should have a PharmD or PhD and 7+ years in regulatory affairs with global filing experience, including CDx development and collaboration with partners.

Qualifications

• PharmD or PhD in science/healthcare.
• Experience leading global regulatory filings (IND/CTA/BLA/MAA).
• Strong knowledge of global regulatory requirements for biologics/cell therapies.

Responsibilities

• Develop and coordinate global regulatory strategies for Legend pipeline programs.
• Lead submissions for INDs, CTAs, and BLAs with timely, high-quality filings.
• Interact with FDA and other health authorities for feedback and alignment on development plans.

Skills

Pharm D or PhD

Regulatory strategy

IND/CTA/BLA filings

Global regulatory knowledge

CDx development

US & ex-US submissions

Communication skills

Education

PharmD or PhD

Job description

Legend Biotech seeks a Director of Regulatory Affairs to independently develop and coordinate global regulatory strategies for its cell therapy programs. Based in Somerset, NJ, the role will interact with health authorities and oversee regulatory filings to ensure timely submissions.

The candidate should have a PharmD or PhD and 7+ years in regulatory affairs with global filing experience, including CDx development and collaboration with partners.