Director, Global Regulatory Affairs – Cell Therapy

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

Benefits offered by this job

Medical

Dental

Vision

401k

Parental leave

Job summary

Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ. You will lead the global regulatory strategies, coordinate cross-functional activities, and oversee regulatory filings for INDs, CTAs, and BLAs to support cell therapy programs.

The role requires a PharmD or PhD with 7+ years of regulatory affairs experience in drug development, strong leadership, and excellent communication. Experience with biologics and CDx is a plus.

Qualifications

• Pharm D or PhD in science or health care field required.
• 7+ years in regulatory affairs for drug development (IND/CTA/BLA).
• Experience with biologics and cell therapies preferred.
• Ability to lead globally and communicate effectively.

Responsibilities

• Develop and coordinate global regulatory strategies for Legend pipeline programs.
• Lead submissions for INDs, CTAs, BLAs and related variations; ensure timely filings.
• Evaluate need for diagnostic tests and companion diagnostics as required.
• Interact with FDA and health authorities to align development strategies.
• Coach junior team members and represent Regulatory Affairs in cross-functional teams.

Skills

Regulatory strategy

IND/CTA/BLA filings

Cross-functional leadership

Regulatory submissions

Global regulatory knowledge

Education

Pharm D or PhD

Job description

Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ. You will lead the global regulatory strategies, coordinate cross-functional activities, and oversee regulatory filings for INDs, CTAs, and BLAs to support cell therapy programs.

The role requires a PharmD or PhD with 7+ years of regulatory affairs experience in drug development, strong leadership, and excellent communication. Experience with biologics and CDx is a plus.