Director, Regulatory Affairs
Legend Biotech
August 18, 2026
On-site
Somerset, NJ
Corporate Functions
Role Overview:
The Director of Regulatory Affairs independently develops, coordinates, and executes global regulatory strategies. Represents Regulatory Affairs on global cross-functional teams, oversees regulatory strategy implementation, interacts with health authorities for feedback/alignment, leads regulatory filings to ensure timely, high-quality submissions, and works closely with a collaboration partner on a key asset.
Key Responsibilities:
- Develop and execute innovative, robust global regulatory strategies for Legend pipeline programs.
- Lead IND/CTA/BLA submissions and related supplements/variations; ensure timely, high-quality submissions.
- Evaluate need for in-vitro diagnostic tests/companion diagnostic tests for pipeline programs.
- Oversee maintenance of INDs, CTAs, BLAs, and ex-U.S. filings.
- Interface with FDA and other health authorities on pre-clinical and clinical development strategies.
- Serve as regulatory representative on global and internal cross-functional teams (e.g., SOP development, business process improvements).
- Represent Regulatory Affairs in external collaborations; review promotional materials (promotional material review committee).
- Coach and mentor junior members.
- Monitor competitive regulatory landscape in oncology, immunology, and cell therapy.
- Provide regular updates to management on pending applications and planned submissions.
Requirements:
- PharmD or PhD (or equivalent in science/healthcare).
- 7+ years regulatory affairs experience in drug development (IND/CTA/BLA/MAA filings/approvals).
- Broad global regulatory knowledge; biologics/cell therapy preferred.
- Experience preparing major regulatory submissions, amendments, and supplements (US and ex-US).
- Good understanding of CDx development; ability to create innovative strategies.
- Excellent communication, strong organizational, and interpersonal skills.
Preferred/Plus:
- Cell and gene therapy experience.
- Multiple myeloma drug development experience.
Benefits and Paid Time Off (as stated):
- Medical/dental/vision; 401(k) with match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays/11 company holidays).
The Director of Regulatory Affairs independently develops, coordinates, and executes global regulatory strategies. Represents Regulatory Affairs on global cross-functional teams, oversees regulatory strategy implementation, interacts with health authorities for feedback/alignment, leads regulatory filings to ensure timely, high-quality submissions, and works closely with a collaboration partner on a key asset.
Key Responsibilities:
- Develop and execute innovative, robust global regulatory strategies for Legend pipeline programs.
- Lead IND/CTA/BLA submissions and related supplements/variations; ensure timely, high-quality submissions.
- Evaluate need for in-vitro diagnostic tests/companion diagnostic tests for pipeline programs.
- Oversee maintenance of INDs, CTAs, BLAs, and ex-U.S. filings.
- Interface with FDA and other health authorities on pre-clinical and clinical development strategies.
- Serve as regulatory representative on global and internal cross-functional teams (e.g., SOP development, business process improvements).
- Represent Regulatory Affairs in external collaborations; review promotional materials (promotional material review committee).
- Coach and mentor junior members.
- Monitor competitive regulatory landscape in oncology, immunology, and cell therapy.
- Provide regular updates to management on pending applications and planned submissions.
Requirements:
- PharmD or PhD (or equivalent in science/healthcare).
- 7+ years regulatory affairs experience in drug development (IND/CTA/BLA/MAA filings/approvals).
- Broad global regulatory knowledge; biologics/cell therapy preferred.
- Experience preparing major regulatory submissions, amendments, and supplements (US and ex-US).
- Good understanding of CDx development; ability to create innovative strategies.
- Excellent communication, strong organizational, and interpersonal skills.
Preferred/Plus:
- Cell and gene therapy experience.
- Multiple myeloma drug development experience.
Benefits and Paid Time Off (as stated):
- Medical/dental/vision; 401(k) with match (vests day one); 8 weeks paid parental leave after 3 months; paid time off (vacation/personal/sick/floating holidays/11 company holidays).