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Senior Regulatory Strategist: CDx & Diagnostics (Remote)

Katalyst CRO, Jacksonville, FL, United States


A healthcare company is seeking a Principal Regulatory Affairs Manager to lead regulatory strategy development and execution for high-complexity diagnostics in a fully remote position. This role involves collaboration with cross-functional teams and requires extensive knowledge of FDA and EU regulations for Companion Diagnostics. Ideal candidates will have a strong track record in regulatory submissions and strategic oversight in product lifecycle management. #J-18808-Ljbffr