Regulatory Affairs Intern at Legend Biotech in Somerset, NJ

Summary: Legend Biotech is a global biotechnology company dedicated to treating and curing life-threatening diseases. The Regulatory Affairs Intern will support the Regulatory team in planning and executing regulatory strategies, submissions, and compliance activities across pipeline programs. 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 Required Qualifications: - Desired Academic Grade Level: MS or Doctorate (e.g. PharmaD, MD, PhD) candidates Important Skills: Regulatory strategies, Regulatory submissions, Regulatory compliance Nice-to-Have Skills: Research skills, Communication skills