Hiring: Director, Regulatory CMC Company: BioSpace Location: Somerset, NJ Job Posted Time: 2026-09-14 13:12:44 Employment Type: Full-time About the job Experience: •10+ years of biotechnology or pharmaceutical industry experience. •7+ years of Regulatory CMC experience supporting biologics, cell and gene therapy. Direct experience with CAR-T cell therapies is desired. Required Skills: •Develop, lead, and execute global CMC regulatory strategies across commercial products and development- stage programs, with primary accountability for late-stage development and post-approval lifecycle management activities. •Provide strategic regulatory leadership to cross-functional teams, influencing development and manufacturing strategies, identifying regulatory risks and opportunities, and driving effective mitigation and contingency plans to support program objectives. •Serve as the primary Regulatory CMC representative on cross-functional program teams and governance committees, ensuring alignment of regulatory strategies with corporate and portfolio goals. •Lead and coordinate regulatory CMC planning, preparation of submissions, and interaction with Health Authorities. •Establish and maintain strong partnerships with internal stakeholders and external collaborators to ensure effective execution of regulatory objectives. •Drive continuous improvement initiatives within the Regulatory CMC function, including development of regulatory processes, best practices, and knowledge management to enhance organizational effectiveness and compliance. •Guide and support junior staff as applicable. Qualifications: •Advanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering, or related discipline. •Strong CMC technical background is required. Ability to critically evaluate data from a broad range of scientific disciplines. •Demonstrated experience leading late-stage programs and post-approval Regulatory CMC experience supporting commercial products, including lifecycle management, supplements, variations, annual reports, and post-approval commitments. •Demonstrated global CMC regulatory experience. •Comprehensive expertise in global CMC requirements on cell and gene therapy. •Expertise in late-stage development and lifecycle management. •Strong leadership, strategic thinking, communication, and technical writing skills. •Demonstrated capacity to manage multiple programs. •The base pay range below is what Legend Biotech USA Inc. reasonably expects to offer at the time of posting. Actual compensation may vary based on experience, skills, qualifications, and geographic location. The company reserves the right to modify this range as needed and in accordance with applicable laws. •Other Types of Pay: Performance-based bonus and/or equity is available to employees in eligible roles. Compensation: •$193,629 - $254,137 / year Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!