Regulatory Affairs Intern

Legend Biotech US • Somerset, NJ

7h

About The Position

Legend Biotech is a global biotechnology company dedicated to treating, and one day curing, life-threatening diseases. Headquartered in Somerset, New Jersey, we are developing advanced cell therapies across a diverse array of technology platforms, including autologous and allogenic chimeric antigen receptor T-cell, T-cell receptor (TCR-T), and natural killer (NK) cell-based immunotherapy. From our three R&D sites around the world, we apply these innovative technologies to pursue the discovery of safe, efficacious and cutting-edge therapeutics for patients worldwide.
Legend Biotech entered into a global collaboration agreement with Janssen, one of the pharmaceutical companies of Johnson & Johnson, to jointly develop and commercialize ciltacabtagene autolecuel (cilta-cel). Our strategic partnership is designed to combine the strengths and expertise of both companies to advance the promise of an immunotherapy in the treatment of multiple myeloma.
Legend Biotech is seeking an Regulatory Affairs Intern as part of the Regulatory Affairs team based in Somerset, NJ.
Role Overview
The Regulatory Affairs Intern will support the Regulatory team in planning and executing regulatory strategies, submissions, and compliance activities across pipeline programs.
This internship is designed for MS or Doctoral candidates pursuing careers in regulatory science, biotechnology, pharmacy, life sciences, or related fields.

Requirements

• Desired Academic Grade Level: MS or Doctorate (e.g. PharmaD, MD, PhD) candidates.

Responsibilities

• Support regulatory intelligence and conduct research and analysis on regulatory guidelines and requirements
• Develop and lead a short-term project aligned such as authoring a regulatory white paper, researching and presenting on a regulatory topic, or supporting execution of a regulatory submission.
• Assist with preparation, formatting, and quality checks of regulatory submissions to health authorities
• Participate in internal meetings with regulatory, clinical, CMC, quality, and project teams to support alignment and decision-making
• Help maintain and organize regulatory documentation, registries, and tracking systems.

Benefits

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

What This Job Offers

• Career Level: Intern