Manager, Regulatory CMC

Legendcareers; New Jersey; On-site; USD 127,000 - 167,000; Full time

Benefits offered by this job

Medical, dental, and vision insurance

401(k) with company match

Parental leave

Paid time off

Job summary

Legend Biotech in Somerset, New Jersey, is seeking a Manager, Regulatory CMC to join the Regulatory Affairs team. The role focuses on global CMC regulatory strategy for pipeline cell and gene therapies, including CAR-T and lentiviral products, with emphasis on authoring and coordinating regulatory submissions.

You will collaborate with Process Development, Manufacturing, Analytical Development, and Quality to translate complex CMC data into clear regulatory documents and ensure compliance across

Qualifications

• Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required; advanced degree (MS, PhD, PharmD) preferred.
• 5+ years of biotechnology or pharmaceutical industry experience with a strong technical background.
• Minimum of 1–2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.
• Experience working with process development, analytical development, or manufacturing teams.
• Experience supporting cell and gene therapies is highly preferred.
• Familiarity with global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Strong scientific writing and document preparation skills with demonstrated experience authoring regulatory submission content.
• Excellent ability to review and translate complex data into clear regulatory documentation.
• Strong project management and organizational skills; able to manage multiple programs and priorities.
• Strong communication and collaboration with cross-functional stakeholders.

Responsibilities

• Support the development and execution of global CMC regulatory strategies for pipeline cell and gene therapy programs, including CAR-T and lentiviral vector products.
• Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts to plan, prepare, review, and coordinate CMC components of global regulatory submissions, includingINDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
• Author, review, and maintain high-quality CMC regulatory documentation to support globaldevelopment, registration, and commercialization activities, ensuring compliance with applicableregulatory requirements and company standards.
• Collaborate with cross-functional technical teams, including Process Development, Manufacturing, Analytical Development, and Quality, to understand complex CMC information and effectively translateit into clear, scientifically sound regulatory submissions.
• Evaluate and interpret technical documentation, including development reports, validation protocols andreports, comparability assessments, and manufacturing change packages, to support regulatory impactassessments, submission strategies, and regulatory decision-making.

Job description

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 aManager, Regulatory CMC as part of theRegulatory Affairs team based inSomerset, NJ.

Role Overview

This position will support the development and execution of global CMC regulatory strategies for pipeline programs, with a strong focus on regulatory dossier authoring and cross-functional collaboration to advance product development milestones.

Key Responsibilities

• Support the development and execution of global CMC regulatory strategies for pipeline cell and genetherapy programs, including CAR-T and lentiviral vector products.
• Partner closely with Regulatory CMC Program Leads and cross-functional subject matter experts toplan, prepare, review, and coordinate CMC components of global regulatory submissions, includingINDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
• Author, review, and maintain high-quality CMC regulatory documentation to support globaldevelopment, registration, and commercialization activities, ensuring compliance with applicableregulatory requirements and company standards.
• Collaborate with cross-functional technical teams, including Process Development, Manufacturing,
• Analytical Development, and Quality, to understand complex CMC information and effectively translateit into clear, scientifically sound regulatory submissions.
• Evaluate and interpret technical documentation, including development reports, validation protocols andreports, comparability assessments, and manufacturing change packages, to support regulatory impactassessments, submission strategies, and regulatory decision-making.

Requirements

• Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline required. Advanced degree (MS, PhD, PharmD) preferred.
• 5+ years of biotechnology or pharmaceutical industry experience with strong technical background.
• Minimum of 1-2 years of Regulatory CMC experience supporting biologics, cell and gene therapy products, or extensive experience authoring and managing CMC sections of regulatory dossiers and submissions.
• Experience working with process development, analytical development, or manufacturing teams.
• Experience supporting cell and gene therapies highly preferred.
• Familiarity with global regulatory requirements, including FDA, EMA, and ICH guidelines.
• Strong scientific understanding and technical background on biologics or cell and gene therapy products.
• Excellent technical writing and document preparation skills with demonstrated experience authoring regulatory submission content.
• Ability to critically review and interpret scientific and technical data and translate complex information into clear regulatory documentation.
• Strong project management and organizational skills.
• Ability to manage multiple programs and competing priorities in a fast-paced environment.
• Strong communication and collaboration skills with cross-functional stakeholders.

#Li-AS1

#Li-Hybrid

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.

• 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):

$127,313 — $167,099 USD

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.

For information related to our privacy notice, please review: Legend Biotech Privacy Notice.