Legend Biotech US

Manager, Regulatory CMC

Legend Biotech US · Somerset, New Jersey, United States

Posted 26 days ago

or apply directly on Legend Biotech US's site. We never take the application ourselves.

Is this posting real?

This role has been open
26 days
Legend Biotech US's roles stay open a median of 40 days
Reposted
No
Salary listed
No
0% of Legend Biotech US's roles list one
Ghost-job risk at Legend Biotech US
high
36 stale, 2 reposted of 79 open
Hiring momentum
125 roles opened in the last 90 days
↑ up vs. the prior 90 days
Last confirmed on the employer's board
2026-09-17

Measured from postings appearing on and disappearing from Legend Biotech US's own greenhouse board since 2026-08-03. Full hiring picture for Legend Biotech US.

About this role

The Manager, Regulatory CMC at Legend Biotech will focus on developing and executing global regulatory strategies for cell and gene therapy programs, particularly CAR-T and lentiviral vector products. This role involves authoring and reviewing regulatory documents, collaborating with cross-functional teams, and ensuring compliance with regulatory requirements to support product development milestones.

Our read on this posting3.0out of 5
benefits
3/5
freshness
4/5
career value
4/5
role clarity
4/5
pay transparency
0/5

Scored from the posting itself — how clearly the role is described, how much it says about pay and benefits, and how recently it was listed. Not a judgement of Legend Biotech US as an employer.

What you need

  • Bachelor's degree in Life Sciences, Biotechnology, Pharmaceutical Sciences, Biochemistry, Chemistry, Engineering, or related discipline
  • 5+ years of biotechnology or pharmaceutical industry experience
  • Minimum of 1-2 years of Regulatory CMC experience supporting biologics or cell and gene therapy products
  • Experience working with process development, analytical development, or manufacturing teams
  • Strong scientific understanding and technical background on biologics or cell and gene therapy products
  • Excellent technical writing and document preparation skills

Nice to have

  • Advanced degree (MS, PhD, PharmD)
  • Experience supporting cell and gene therapies
  • Familiarity with global regulatory requirements, including FDA, EMA, and ICH guidelines

What you get

  • Medical, dental, and vision insurance
  • 401(k) retirement plan with a company match that vests fully on day one
  • Eight weeks of paid parental leave after three months of employment
  • Paid time off policy including vacation time, personal time, sick time, floating holidays, and eleven company holidays
  • Voluntary benefits including flexible spending and health savings accounts, life and AD&D insurance, short- and long-term disability coverage, legal assistance, and supplemental plans
  • Voluntary commuter benefits, family planning and care resources, well-being initiatives, and peer-to-peer recognition programs

Worth weighing

  • No specific information on the company's culture or team dynamics is provided
  • The role requires managing multiple programs and competing priorities in a fast-paced environment, which may indicate a high-pressure work setting

Summarised from Legend Biotech US's posting. Read the full original.

Listed by Legend Biotech US on their greenhouse job board, last confirmed open on 2026-09-17. PitchMeAI is not the employer.

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