Director, Regulatory Affairs

Legend Biotech USA; New Jersey; On-site; USD 180,000 - 240,000; Full time

Benefits offered by this job

Benefits for permanent full-time

Job summary

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.

Qualifications

• 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.

Responsibilities

• 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.

Skills

Regulatory strategy

IND/CTA/BLA submissions

Leadership

Cross-functional collaboration

Communication skills

CDx development

Cell and gene therapy

Global regulatory knowledge

Education

Pharm D or PhD

Job description

Legend Biotech is seeking a Director, Regulatory Affairs as part of the Regulatory Affairs team based in Somerset, NJ.

Role Overview

The Director of Regulatory Affairs is responsible for independently developing, coordinating and executing the global regulatory strategies. The Director will represent Regulatory Affairs on global cross-functional teams and provide oversight on regulatory strategy implementation for the assets. The Director will interact with health authorities to seek feedback and reach alignment on regulatory strategies; oversee activities for regulatory filings and ensure timely and high-quality submissions. The Director will also work closely with collaboration partner on a key asset.

Key Responsibilities

• Responsible to independently develop innovative, robust global regulatory strategies and ensure their efficient and effective execution for Legend pipeline programs.
• Lead the team efforts required for the submission of INDs, CTAs, and BLAs as well as related supplements/variations; ensure timely and high-quality submissions.
• Lead the effort to evaluate the need to develop in-vitro diagnostic test or companion diagnostic tests for pipeline programs as needed.
• Oversee the maintenance of INDs, CTAs and BLAs, and ex-U.S. filings as required.
• Interface with the FDA and other health authorities to seek feedback and alignment on pre-clinical and clinical development strategies.
• Serves as regulatory representative in global cross-functional development teams for pipeline programs; work closely with other line functions to ensure efficient execution of regulatory strategies.
• Serve as regulatory representative in internal cross-functional teams for activities such as SOP development, business process improvements, etc.
• Represent Legend regulatory affairs in external collaborations.
• Serve as the regulatory affairs reviewer in the promotional material review committee.
• Coach and mentor junior members in their roles on global project teams.
• Have a good understanding of the competitive regulatory landscape in oncology, immunology and cell therapy.
• Provides regular and timely updates to management on the status of all pending applications and planned submissions as necessary.

Requirements

• A Pharm D or PhD Degree, or equivalent in a science or health care 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 and regulations on drug development, experience in biologics and cell therapies is preferred
• Ability to independently formulate and lead the team to execute global regulatory strategies
• Experienced in the preparation of major regulatory submissions,amendments and supplements in US and ex-US countries
• Good understanding on CDx development
• Able to think out of the box, formulate innovative regulatory strategies to speed up clinical development
• Demonstrate excellent communication skills.
• Demonstrate strong organizational skills, including the ability to prioritize
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, clinical, and manufacturing representatives
• Experience in cell and gene therapy is a plus
• Experience in drug development in multiple myeloma is a plus
• Language(s): English

Legend Biotech is a global biotechnology company dedicated to treating and, one day, curing life-threatening diseases. Headquartered in Bridgewater, New Jersey, we are advancing the next generation of cell therapy through a portfolio of innovative technologies, including autologous, allogeneic, and in vivo cell therapy approaches. Our research spans chimeric antigen receptor T-cell (CAR-T), T-cell receptor (TCR-T), natural killer (NK) cell-based therapies, and other emerging platforms designed to transform the treatment of serious diseases. From our global network of research and development sites, we are committed to discovering and developing safe, effective, and cutting-edge therapies for patients worldwide.

Legend Biotech entered into a global collaboration agreement with Johnson & Johnson to jointly develop and commercialize CARVYKTI® (ciltacabtagene autoleucel; cilta-cel). Through this strategic partnership, we combine complementary expertise and capabilities to advance innovative immunotherapies for patients living with multiple myeloma.

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

Work Authorization & Employment Eligibility

Applicants must be authorized to work in the United States. As part of our commitment to maintaining a lawful workforce and ensuring compliance with federal employment regulations, we participate in the E-Verify program. If you are selected for employment, you will be required to complete the Form I-9 process, and your employment eligibility will be verified through E-Verify in accordance with applicable federal law. We are committed to providing a fair, transparent, and welcoming hiring experience for all candidates.

EEO Statement

It is the policy of Legend Biotech to provide equal employment opportunities without regard to actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, related medical conditions and lactation), gender identity or gender expression (including transgender status), sexual orientation, marital status, military service and veteran status, disability, genetic information, or any other protected characteristic under applicable federal, state or local laws or ordinances.

Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company.

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