Director, Regulatory CMC

Legend Biotech US • Somerset, NJ

6d • Hybrid

About The Position

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ.

Requirements

• Advanced degree in life sciences
• 10 years of experience in biotechnology, analytics or pharmaceutical technology. Knowledge of viral vector technology is required. Ability to critically evaluate data from a broad range of scientific disciplines.
• At least 5 years of experience in CMC regulatory affairs supporting viral vector product development, with a preference for experience in late-stage development.
• Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs and IMPDs.
• Proven track record to successfully support viral vector product development.
• Proven track record to successfully work in interdisciplinary teams, planning, and coordinating.
• Effective planning, organizational and interpersonal skills.
• Good technical writing skills.

Responsibilities

• Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy for multiple platforms.
• Provides guidance to technical team members for the requirements, especially on the unique requirements on different platform technologies. Identify the required documentation to support global submissions and coordinate the delivery of approved technical source documents in accordance with project timelines.
• Provide guidance on product development at the R&D phase leveraging different advanced platform technologies.
• Coordinates and manages CMC regulatory submissions, applying CMC global regulatory strategies.
• Prepare briefing books for Health Authority meetings.
• Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance.
• Establish and maintain sound working relationships with partners and customers.
• Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Guide and Support Junior Staff.

Benefits

• We are committed to creating a workplace where employees can thrive - both professionally and personally. To attract and retain top talent in a highly competitive industry, we offer a best-in-class benefits package that supports well-being, financial stability, and long-term career growth.
• Our offerings are designed to meet the diverse needs of our team members and their families, ensuring they feel valued and supported every step of the way. Highlights include medical, dental, and vision insurance as well as a 401(k)-retirement plan with company match that vest fully on day one.
• Equity and stock options are available to employees in eligible roles. We offer eight weeks of paid parental leave after just three months of employment, and a paid time off policy that includes vacation days, personal days, sick time, 11 company holidays, and 3 floating holidays.
• Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance.
• We also provide commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs - demonstrating our ongoing commitment to building a culture where our people feel empowered, supported, and inspired to do their best work.
• Please note: These benefits are offered exclusively to permanent employees. Contract employees are not eligible for benefits through Legend Biotech.

What This Job Offers

• Job Type: Full-time
• Career Level: Director
• Number of Employees: 1,001-5,000 employees