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Regulatory Specialist/Affairs

8194 Natures Way unit 1, Lakewood Ranch, FL 34202, USA


The Kwality Group, LLC

Job Description

We’re seeking a dedicated and compassionate Regulatory Specialist/Affair to join our team.

This individual delivers high-level research administration support and is responsible for managing research processes, activities and obligations in accordance with relevant legislation and regulations, policy, guidelines and applicable collective agreement(s) and standard operating procedures. He or she is typically responsible for drafting or editing the protocol document and submitting new protocols, protocol amendments, continuing reviews and safety reports to the appropriate IRB for review. They are responsible for maintaining regulatory binders in accordance with sponsor specifications and general industry standards. They often are the keepers of the delegation of authority log for key personnel involved in the study.

Minimum Qualifications:

  • A bachelor's degree in a related field and eight (8) years experience in clinical trials, two of which are in the clinical area.

  • OR a master's degree and four years of experience in clinical trials

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