Associate Director, Regulatory Affairs-CMC

The Associate Director, Regulatory Affairs - CMC is responsible for providing regulatory leadership and guidance to CMC teams developing cell and gene therapy products, including the oversight and generation of quality dossiers to support Health Authority meetings, clinical trial applications and market applications in the U.S. and multiple international territories.

Requirements

• Bachelor's degree or equivalent in Regulatory Science or related field
• 6 years of experience in Regulatory Affairs, CMC
• Experience in a global pharmaceutical and/or biotechnology company with expertise in biologicals, therapeutic proteins, and/or cell and gene therapy products
• Direct experience interfacing with regulatory authorities
• Experience preparing quality sections of regulatory filings
• Ability to lead regulatory CMC discussions with global regulatory authorities
• Experience preparing electronic submissions following eCTD format
• Knowledge and understanding of US, international regulations, and ICH guidelines related to biologics and cell therapy development
• Experience leading the development and implementation of complex regulatory strategies
• Ability to understand technical aspects of manufacturing and quality control assays
• Strong interpersonal skills and the ability to collaborate effectively with various technical area experts
• Excellent written and communication skills with attention to detail
• Highly computer literate (Word, Excel PowerPoint), including formatting documents for regulatory submission

Benefits

• Generous Paid Time Off
• 401k Matching
• Retirement Plan
• Visa Sponsorship