Regulatory Strategy Expert - NGS
209819
Posted: 27/02/2025
- Remote/Hybrid
- Permanent
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).
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Kyle Dorion
Senior Consultant
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