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Vaccine Regulatory Strategy Lead

Job in Gaithersburg, Montgomery County, Maryland, 20883, USA
Listing for: GAP Solutions Inc
Full Time position
Listed on 2026-08-26
Job specializations:
  • Business
    Regulatory Compliance Specialist
Salary/Wage Range or Industry Benchmark: 120000 - 180000 USD Yearly USD 120000.00 180000.00 YEAR
Job Description & How to Apply Below

GAP Solutions Inc. seeks a Scientific Program Manager to support NIAID/NIH. You will lead regulatory strategy for INDs involving vaccines and monoclonal antibodies, ensuring FDA compliance across development stages.

You will prepare and review regulatory documentation (cGCP, GLP, cGMP), interact with FDA project managers, and advise the Director on strategies to advance candidates to the clinic. Strong communication is essential.

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