Global Regulatory Affairs Director - Cell Therapy & IND/CTA

Legend Biotech USA; New Jersey; Vor Ort; USD 180.000 - 240.000; Vollzeit

Benefits dieser Stelle

Benefits for permanent full-time

Zusammenfassung

Legend Biotech USA is seeking a Director of Regulatory Affairs in Somerset, NJ. You will independently develop and execute global regulatory strategies, for oncology/cell therapy programs, and lead IND/CTA/BLA submissions with cross-functional teams.

You will interact with health authorities, oversee major submissions, and mentor junior staff while collaborating with partners on asset development and regulatory strategy alignment.

Qualifikationen

• A Pharm D or PhD in science or health care is required.
• Minimum 7+ years in regulatory affairs focused on IND/CTA/BLA/MAA filings.
• Global regulatory requirements, biologics and cell therapies knowledge preferred.
• Ability to independently formulate and lead global regulatory strategies.
• Experience preparing major regulatory submissions in US and ex-US.

Aufgaben

• Develop and execute global regulatory strategies independently.
• Lead IND/CTA/BLA submissions and related supplements/variations with timely, high-quality filings.
• Evaluate need for diagnostic/companion diagnostic tests for pipeline programs.
• Maintain INDs, CTAs, BLAs and ex-US filings as required.
• Interface with FDA and health authorities to align on development strategies.
• Represent Regulatory Affairs in cross-functional development teams and internal committees.
• Coach and mentor junior team members on global projects.

Kenntnisse

Regulatory strategy

IND/CTA/BLA submissions

Leadership

Cross-functional collaboration

Communication skills

CDx development

Cell and gene therapy

Global regulatory knowledge

Ausbildung

Pharm D or PhD

Jobbeschreibung

Legend Biotech USA is seeking a Director of Regulatory Affairs in Somerset, NJ. You will independently develop and execute global regulatory strategies, for oncology/cell therapy programs, and lead IND/CTA/BLA submissions with cross-functional teams.

You will interact with health authorities, oversee major submissions, and mentor junior staff while collaborating with partners on asset development and regulatory strategy alignment.