Legend Biotech US
Overview
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 CAR-T, TCR-T, and NK cell-based immunotherapy. From our three R&D sites around the world, we pursue discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech is seeking a Director, Regulatory CMC
as part of the
Regulatory Affairs
team based in
Somerset, NJ . Key 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 on requirements, especially for different platform technologies; identifies required documentation to support global submissions and coordinates delivery of approved technical source documents within project timelines. Guides product development at the R&D phase leveraging different advanced platform technologies. Coordinates and manages CMC regulatory submissions, applying global regulatory strategies. Prepares briefing books for Health Authority meetings. Facilitates consistency within the CMC regulatory documentation by sharing experience and contributing to template maintenance. Establishes and maintains sound working relationships with partners and customers. Keeps knowledge up to date with regulatory guidelines and requirements across global regions and for new technical trends. Guides and supports junior staff. 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 late-stage development experience. 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 ability to work in interdisciplinary teams, planning and coordinating. Effective planning, organizational and interpersonal skills. Good technical writing skills. Compensation The anticipated base pay range for this role is: $187,989 - $258,485 USD. Benefits Legend Biotech offers a best-in-class benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; and a comprehensive paid time off policy (15 vacation days, 5 personal days, 5 sick days, 11 U.S. holidays, and 3 floating holidays). Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, disability coverage, legal assistance, and supplemental plans. We also provide commuter benefits, family planning resources, well-being initiatives, and peer-to-peer recognition programs to support a diverse and inclusive culture. EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend Biotech maintains a drug-free workplace. Apply for this job
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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 CAR-T, TCR-T, and NK cell-based immunotherapy. From our three R&D sites around the world, we pursue discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide. Legend Biotech is seeking a Director, Regulatory CMC
as part of the
Regulatory Affairs
team based in
Somerset, NJ . Key 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 on requirements, especially for different platform technologies; identifies required documentation to support global submissions and coordinates delivery of approved technical source documents within project timelines. Guides product development at the R&D phase leveraging different advanced platform technologies. Coordinates and manages CMC regulatory submissions, applying global regulatory strategies. Prepares briefing books for Health Authority meetings. Facilitates consistency within the CMC regulatory documentation by sharing experience and contributing to template maintenance. Establishes and maintains sound working relationships with partners and customers. Keeps knowledge up to date with regulatory guidelines and requirements across global regions and for new technical trends. Guides and supports junior staff. 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 late-stage development experience. 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 ability to work in interdisciplinary teams, planning and coordinating. Effective planning, organizational and interpersonal skills. Good technical writing skills. Compensation The anticipated base pay range for this role is: $187,989 - $258,485 USD. Benefits Legend Biotech offers a best-in-class benefits package designed to support well-being, financial stability, and long-term career growth. Highlights include medical, dental, and vision insurance; a 401(k) retirement plan with company match; equity and stock options for eligible roles; eight weeks of paid parental leave after three months of employment; and a comprehensive paid time off policy (15 vacation days, 5 personal days, 5 sick days, 11 U.S. holidays, and 3 floating holidays). Additional benefits include flexible spending and health savings accounts, life and AD&D insurance, disability coverage, legal assistance, and supplemental plans. We also provide commuter benefits, family planning resources, well-being initiatives, and peer-to-peer recognition programs to support a diverse and inclusive culture. EEO Statement Legend Biotech is an equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital status, or any other characteristic protected by applicable law. Employment is at-will and may be terminated at any time with or without cause or notice by the employee or the company. Legend Biotech maintains a drug-free workplace. Apply for this job
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