Director, Regulatory CMC

Legend Biotech is seeking a Director, Regulatory CMC as part of the Regulatory Affairs team based in Somerset, NJ.

Key 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.
  
  
  

Requirements

• 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.
  
  
  

Legend Biotech is a proud equal opportunity/affirmative action employer committed to attracting, retaining, and maximizing the performance of a diverse and inclusive workforce. It is Legend’s policy to ensure equal employment opportunity without discrimination or harassment based on race, color, religion, sex (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity or expression, age, disability, national origin, marital or domestic/civil partnership status, genetic information, citizenship status, uniformed service member or veteran status, or any other characteristic protected by law.

Legend Biotech maintains a drug-free workplace.

Benefits:

• Health Insurance
• Dental Insurance
• Vision Insurance
• Life Insurance
• Matched 401K
• Flexible Spending Account
• Health Savings Account
• AD&D Insurance
• Short-Term Disability
• Long-Term Disability
• Paid Maternity Leave
• Paid Paternity Leave
• Pet Insurance
• Critical Illness Insurance
• Hospital Indemnity Insurance
• Accident Insurance
• Legal Insurance
• Commuter Benefits
• Employee Assistance Program