Director, Regulatory CMCKey Responsibilities- 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.
Requirements- Advanced degree in life sciences, biotechnology, pharmaceutical sciences, engineering, or related discipline.
- 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.
- 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.
- Deep understanding of 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.
- Ability to manage multiple programs.
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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.
Benefits and Paid Time Off: Medical, dental, and vision insurance as well as a 401(k) retirement plan with a company match that vests fully on day one. We offer eight (8) weeks of paid parental leave after just three (3) months of employment, and a paid time off policy that includes vacation time, personal time, sick time, floating holidays, and eleven (11) company holidays. Additional voluntary 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 voluntary 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.
Pay Range (Base Pay):
$193,629-$254,137 USD
Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech. 
