Legend Biotech · 1 day ago
Director, Regulatory CMC
Somerset, NJ
Full-time
Onsite
Director/Executive
$188K/yr - $258K/yr
10+ years expLegend Biotech is a global biotechnology company dedicated to treating life-threatening diseases. The Director, Regulatory CMC will serve as the regulatory CMC representative on core teams, develop regulatory submission strategies, and guide product development leveraging advanced platform technologies.
BiotechnologyHealth CareLife ScienceOncologyTherapeutics
Hiring Manager
Justin Kerno
Responsibilities
Serves as the regulatory CMC representative on core teams, develops and plans regulatory CMC submission strategy for multiple platforms
Provides guidance to technical team members for the requirements, especially on the unique requirements on different platform technologies. Identify the required documentation to support global submissions and coordinate the delivery of approved technical source documents in accordance with project timelines
Provide guidance on product development at the R&D phase leveraging different advanced platform technologies
Coordinates and manages CMC regulatory submissions, applying CMC global regulatory strategies
Prepare briefing books for Health Authority meetings
Facilitate consistency within the CMC regulatory documentation by sharing experience and/or contributing to template maintenance
Establish and maintain sound working relationships with partners and customers
Keep knowledge up to date with regard to regulatory guidelines and requirements in all global regions as well as for new technical trends
Guide and Support Junior Staff
Qualification
Required
Advanced degree in life sciences
10 years of experience in biotechnology, analytics or pharmaceutical technology. Knowledge of viral vector technology is required. Ability to critically evaluate data from a broad range of scientific disciplines
At least 5 years of experience in CMC regulatory affairs supporting viral vector product development, with a preference for experience in late-stage development
Solid knowledge of regulatory submission procedures including CMC requirements for filing and maintaining INDs and IMPDs
Proven track record to successfully support viral vector product development
Proven track record to successfully work in interdisciplinary teams, planning, and coordinating
Effective planning, organizational and interpersonal skills
Good technical writing skills
Benefits
Medical, dental, and vision insurance
401(k)-retirement plan with company match that vest fully on day one
Equity and stock options
Eight weeks of paid parental leave after just three months of employment
Paid time off policy that includes 15 vacation days, 5 personal days, 5 sick days, 11 U.S. national holidays, and 3 floating holidays
Flexible spending and health savings accounts
Life and AD&D insurance
Short- and long-term disability coverage
Legal assistance
Supplemental plans such as pet, critical illness, accident, and hospital indemnity insurance
Commuter benefits
Family planning and care resources
Well-being initiatives
Peer-to-peer recognition programs
Company
Legend Biotech
Legend Biotech is a biopharmaceutical company that develops and commercializes novel cell therapies for oncology.
1001-5000 employees
H1B Sponsorship
Legend Biotech has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (30)
2024 (11)
2023 (14)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Public CompanyTotal Funding
$750.45M2023-05-05Post Ipo Equity· $350M
2022-07-25Post Ipo Equity· $250M
2020-06-05IPO
Leadership Team
Carlos Santos
Chief Financial Officer
Alan Bash
President, CARVYKTI
Recent News
2025-12-18
thefly.com
2025-12-09
Company data provided by crunchbase