Director, Regulatory CMC

Job Description

Legend Biotech is seeking a Director, Regulatory CMC to join their Regulatory Affairs team in Somerset, NJ. This role involves developing and implementing regulatory CMC submission strategies across multiple platforms. The Director will provide guidance to technical teams, identify necessary documentation for global submissions, and coordinate the delivery of technical source documents. They will also offer guidance on product development during the R&D phase, manage CMC regulatory submissions, and prepare briefing books for Health Authority meetings.

• Serving as the regulatory CMC representative on core teams
• Developing and planning regulatory CMC submission strategies
• Providing guidance to technical team members
• Identifying required documentation for global submissions
• Coordinating and managing CMC regulatory submissions
• Preparing briefing books for Health Authority meetings

Requirements:

• Advanced degree in life sciences
• 10 years of experience in biotechnology, analytics, or pharmaceutical technology
• Knowledge of viral vector technology
• 5 years of experience in CMC regulatory affairs supporting viral vector product development
• Solid knowledge of regulatory submission procedures
• Proven track record of successful support for viral vector product development
• Effective planning, organizational, and interpersonal skills
• Good technical writing skills

Legend Biotech offers:

• A hybrid work environment
• Equal opportunity employment