Director, Regulatory Affairs
Legend Biotech US · Somerset, New Jersey, United States
Posted 29 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
- 29 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 Director of Regulatory Affairs at Legend Biotech will independently develop and execute global regulatory strategies for the company's pipeline programs. This role involves leading submissions for INDs, CTAs, and BLAs, interacting with health authorities, and overseeing regulatory filings. Additionally, the Director will mentor junior team members and represent regulatory affairs in cross-functional teams and external collaborations.
- benefits
- 3/5
- freshness
- 4/5
- career value
- 4/5
- role clarity
- 5/5
- 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
- A Pharm D or PhD Degree, or equivalent in a science or health care field
- A minimum of 7+ years of experience in regulatory affairs in drug development
- Broad and in-depth knowledge of global regulatory requirements and regulations on drug development
- Ability to independently formulate and lead the team to execute global regulatory strategies
- Experienced in the preparation of major regulatory submissions, amendments and supplements in US and ex-US countries
- Good understanding on CDx development
Nice to have
- Experience in cell and gene therapy
- Experience in drug development in multiple myeloma
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 mention of remote work options, though 'Li-Hybrid' suggests some flexibility
- The role requires significant experience, which may limit opportunities for less experienced candidates
- The job involves high-stakes regulatory responsibilities, which may be stressful
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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