Global Director, Regulatory Affairs - Cell Therapy

Legend Biotech US; New Jersey; On-site; USD 194,000 - 254,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) company match

Paid parental leave

Paid time off (vacation, personal, and

sick time

Job summary

Legend Biotech US seeks a Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies and oversee submissions for the company’s cell therapy programs. You will interact with health authorities, coordinate cross-functional teams, and mentor staff to ensure timely, high-quality IND/CTA/BLA filings.

The role requires a PharmD or PhD, 7+ years in regulatory affairs, and deep knowledge of global regulations for biologics and cell therapies; oncology experience is a plus.

Qualifications

• A Pharm D or PhD degree, or equivalent in a science or healthcare field is required.
• A minimum of 7+ years of experience in regulatory affairs in drug development, focusing on filing and approval process in IND/CTA/BLA/MAA.
• Broad and in-depth knowledge of global regulatory requirements; experience in biologics and cell therapies is preferred.
• Ability to independently formulate and lead the team to execute global regulatory strategies.
• Experience in major regulatory submissions, amendments and supplements in US and ex-US.
• Ability to think creatively and speed up clinical development with innovative strategies.
• Strong organizational skills and prioritization abilities.
• Strong interpersonal skills for interaction with medical, clinical, and manufacturing representatives.
• Experience in cell and gene therapy is a plus.
• Experience in drug development in multiple myeloma is a plus.

Responsibilities

• Independently develop global regulatory strategies for Legend pipeline programs.
• Lead submissions for INDs, CTAs, and BLAs with timely, high-quality filings.
• Evaluate need for in-vitro diagnostic or companion diagnostic tests as needed.
• Maintain INDs, CTAs, BLAs and ex-US filings.
• Interface with FDA and health authorities to align on development strategies.
• Represent Regulatory Affairs on global cross-functional teams.
• Coach and mentor junior members on global projects.
• Understand competitive regulatory landscape in oncology, immunology and cell therapy.
• Provide regular updates to management on pending applications and submissions.

Skills

Regulatory strategy leadership

IND/CTA/BLA submissions

Global regulatory knowledge

Cross-functional collaboration

Mentorship

Education

PharmD or PhD in science/healthcare

Job description

Legend Biotech US seeks a Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies and oversee submissions for the company’s cell therapy programs. You will interact with health authorities, coordinate cross-functional teams, and mentor staff to ensure timely, high-quality IND/CTA/BLA filings.

The role requires a PharmD or PhD, 7+ years in regulatory affairs, and deep knowledge of global regulations for biologics and cell therapies; oncology experience is a plus.