Regulatory Strategy Expert - NGS

Barrington James is looking for a Regulatory Strategy SME to work on a remote assignment with a client of ours located in CA. This is a client that is focused in the Cell and Gene Therapy space and they are looking to bring in a SME to help build out their regulatory strategy program.

Role Focus

• Develop and define a regulatory strategy that balances confirmatory testing requirements with method refinement.
  
  

Key Expertise

• Extensive regulatory experience, particularly in interactions with the FDA regarding NGS sequencing and validation processes.
• Ability to design and support a concurrent strategy addressing both method improvement and regulatory arguments (e.g., optimizing testing protocols to mitigate known issues).
• Background in quality control and compliance in a regulated environment (pharma, gene therapy, or related sectors is preferred).