Regulatory Diagnostics Manager
Company: VirtualVocations
Location: Jackson Heights
Posted on: September 19, 2023
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Job Description:
A company is looking for a Manager, Regulatory Diagnostics.
Key Responsibilities:
Develop and coordinate IVD related regulatory submissions in line
with program strategies
Lead authoring of IVD related regulatory documentation
Interface with outside regulatory agencies for application
submission and management
Required Qualifications:
Bachelor's degree required; advanced degree preferred
Minimum of 5 years of experience in the biotechnical or
pharmaceutical industry
Minimum of 2 years experience in a regulatory capacity, or 5 years
of experience with in-vitro diagnostic development for companion
diagnostics
Experience with FDA and ICH regulatory guidance and regulations
Understanding of FDA structure and functions; knowledge
of/experience with regulatory requirements for other regions also
desirable
Keywords: VirtualVocations, New York , Regulatory Diagnostics Manager, Executive , Jackson Heights, New York
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