Associate Dir, Regulatory Affairs - Cell Therapy (Equity)

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

Benefits offered by this job

Medical, dental, and vision insurance

401(k) retirement plan with company 1:

Paid parental leave

Paid time off

Flexible spending and HSA options

Life and AD&D insurance

Disability coverage

Job summary

Legend Biotech seeks an Associate Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies for cell-therapy assets. You will coordinate IND/CTA/BLA submissions and liaise with FDA and global authorities to align on development plans.

The role requires a PharmD or PhD with 5+ years in regulatory affairs for biologics/cell therapies, and strong leadership and communication skills.

Qualifications

• Requires PharmD or PhD in science or healthcare.
• Experience with regulatory submissions in US and ex-US.
• Knowledge of CDx development and oncology regulatory landscape.

Responsibilities

• Develop and coordinate global regulatory strategies for Legend assets.
• Lead IND/CTA/BLA submissions and related supplements/variations.
• Interface with FDA and health authorities on strategies and feedback.
• Oversee regulatory filings, maintain INDs/CTAs/BLAs and ex-US filings.
• Coach junior team members on cross-functional project teams.
• Represent Regulatory Affairs in cross-functional internal teams.

Skills

Regulatory strategy leadership

IND/CTA/BLA submissions

Global regulatory knowledge

Biologics / cell therapy experience

Excellent communication

Team leadership

Education

PharmD or PhD in science/healthcare

Job description

Legend Biotech seeks an Associate Director, Regulatory Affairs in Somerset, NJ to lead global regulatory strategies for cell-therapy assets. You will coordinate IND/CTA/BLA submissions and liaise with FDA and global authorities to align on development plans.

The role requires a PharmD or PhD with 5+ years in regulatory affairs for biologics/cell therapies, and strong leadership and communication skills.