Director, Regulatory Affairs

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.

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 coordinatingand executing the global regulatory strategies. The Director will represent Regulatory Affairson global cross-functional teams and provide oversight on regulatory strategy implementationfor the assets. The Director will interact with health authorities to seek feedback and reachalignment on regulatory strategies; oversee activities for regulatory filings and ensure timelyand high-quality submissions. The Director will also work closely with collaboration partner ona 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

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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.