Global Regulatory Strategy Director, Cell Therapy

BioSpace; 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 so

Eight weeks paid parental leave

Paid time off including vacation, sick

Job summary

Legend Biotech is seeking a Director, Regulatory Affairs to lead global regulatory strategies for the Somerset, NJ‑based assets. The role requires coordinating cross‑functional teams and interfacing with health authorities to drive timely submissions.

The Director will oversee INDs, CTAs and BLAs, explore diagnostic test strategies, and mentor junior staff across US and ex-US programs in oncology and cell therapy.

Qualifications

• Pharm D or PhD in science or healthcare field required.
• 7+ years of regulatory affairs experience in drug development (IND/CTA/BLA/MAA).
• Experience with biologics and cell therapies preferred.
• Ability to independently formulate and lead global regulatory strategies.
• Experience in preparation of major regulatory submissions in US and ex-US.
• Good understanding of CDx development.
• Strong communication and organizational skills.
• Experience in cell and gene therapy a plus.
• English language proficiency required.

Responsibilities

• Develop innovative global regulatory strategies and oversee their execution for Legend pipeline programs.
• Lead IND/CTA/BLA filings and related supplements/variations with timely, high-quality submissions.
• Evaluate need for in‑vitro diagnostic or companion diagnostic tests for pipeline programs as needed.
• Oversee maintenance of INDs, CTAs and BLAs, including ex-US filings as required.
• Interface with FDA and other health authorities for feedback and alignment on development strategies.
• Represent regulatory affairs in cross-functional teams during development and through submissions.
• Participate in SOP development and business process improvements as regulatory expert.
• Act as regulatory representative in collaborations with external partners.
• Review promotional materials from a regulatory perspective.
• Coach and mentor junior staff on global projects.
• Maintain awareness of oncology, immunology and cell therapy regulatory landscapes.
• Provide regular updates to management on pending applications and planned submissions.

Skills

Regulatory affairs

Leadership

IND/CTA/BLA

CDx knowledge

Biologics

Cell therapy

Communication

Project management

Education

Pharm D or PhD in science/healthcare

Job description

Legend Biotech is seeking a Director, Regulatory Affairs to lead global regulatory strategies for the Somerset, NJ‑based assets. The role requires coordinating cross‑functional teams and interfacing with health authorities to drive timely submissions.

The Director will oversee INDs, CTAs and BLAs, explore diagnostic test strategies, and mentor junior staff across US and ex-US programs in oncology and cell therapy.