Global Regulatory Strategy Lead – Cell Therapy

BioNJ Inc.; New Jersey; In loco; USD 150.000 - 210.000; Tempo pieno

Descrizione del lavoro

Legend Biotech, based in Somerset, NJ, is seeking an Associate Director, Regulatory Affairs to independently develop and execute global regulatory strategies for its pipeline. You will lead regulatory filings (INDs, CTAs, BLAs) and collaborate with cross-functional teams to ensure timely, high-quality submissions.

The role requires a PharmD or PhD and 5+ years in regulatory affairs with exposure to biologics or cell therapies.

Competenze

• Requires PharmD or PhD in science/healthcare.
• Minimum 5+ years in regulatory affairs for drug development (IND/CTA/BLA).
• Global regulatory requirements knowledge; biologics/cell therapies preferred.
• Able to independently lead teams and execute global regulatory strategies.
• Experience preparing major regulatory submissions in US and ex-US.

Mansioni

• Develop and coordinate global regulatory strategies and oversee submissions.
• Lead IND/CTA/BLA submissions and related supplements/variations with timely, high-quality deliverables.
• Evaluate/advise on development of diagnostic or companion diagnostic tests as needed.
• Interact with FDA and other authorities to align on preclinical/clinical strategies; represent Regulatory Affairs on cross-functional teams.
• Mentor junior team members and stay informed on oncology, immunology and cell therapy regulatory landscape.

Conoscenze

Regulatory Strategy

IND/CTA filings

Cross-functional leadership

FDA interactions

CDx understanding

Cell therapy

Communication skills

Project management

Biologics

Oncology

Formazione

PharmD or PhD

Descrizione del lavoro

Legend Biotech, based in Somerset, NJ, is seeking an Associate Director, Regulatory Affairs to independently develop and execute global regulatory strategies for its pipeline. You will lead regulatory filings (INDs, CTAs, BLAs) and collaborate with cross-functional teams to ensure timely, high-quality submissions.

The role requires a PharmD or PhD and 5+ years in regulatory affairs with exposure to biologics or cell therapies.