Manager, Regulatory CMC

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

Benefits offered by this job

Medical, dental, vision insurance

401(k) with company match

Paid parental leave

Job summary

Legend Biotech in Bridgewater, New Jersey, seeks a Manager, Regulatory CMC to drive global regulatory strategies for pipeline cell and gene therapies, with a strong focus on dossier authoring and cross-functional collaboration. You will coordinate submissions and maintain high-quality regulatory documents to support development and commercialization.

The role requires 5+ years in biotechnology/pharma, with CMC experience, and familiarity with FDA, EMA, and ICH guidelines. A MS/PhD is preferred.

Qualifications

• Bachelor's degree in Life Sciences or related field; advanced degree preferred.
• 5+ years biotechnology/pharma experience with strong technical background.
• 1–2 years Regulatory CMC experience with biologics or cell/gene therapy.
• Experience with process development, analytical development, or manufacturing teams.
• Experience with FDA, EMA, ICH guidelines.

Responsibilities

• Support global CMC regulatory strategies for pipeline cell and gene therapy programs.
• Coordinate CMC components of regulatory submissions (INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses).
• Author, review, and maintain CMC regulatory documentation to support global development and commercialization.
• Collaborate with cross-functional teams including Process Development, Manufacturing, Analytical Development, and QA.
• Translate complex CMC data into clear, scientifically sound regulatory submissions.

Skills

Regulatory CMC

Biologics

Cell & Gene Therapy

Regulatory Submissions

Technical Writing

Cross-functional Collaboration

Project Management

Regulatory Knowledge

Education

Bachelor's in Life Sciences

MS/PhD preferred

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.

Manager, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, 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 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, including INDs, CTAs, BLAs, MAAs, amendments, supplements, and responses to Health Authority requests.
• Author, review, and maintain high-quality CMC regulatory documentation to support global development, registration, and commercialization activities, ensuring compliance with applicable regulatory 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 translate it into clear, scientifically sound regulatory submissions.
• Evaluate and interpret technical documentation, including development reports, validation protocols and reports, comparability assessments, and manufacturing change packages, to support regulatory impact assessments, 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.

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): $127,313 USD - $167,099 USD

Please note: These benefits are offered exclusively to permanent full-time employees. Contractors are not eligible for benefits through Legend Biotech.

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.