Drug Regulatory Specialist

Class Concept

Work in this class involves protecting the health and welfare of the public by accurately interpreting and uniformly enforcing the requirements of the North Carolina Food, Drug, and Cosmetic Act; the Wholesale Drug Distributor Licensing Act of 1991; and their attendant regulations as they apply to the manufacture, transport, storage, and sale of drugs, cosmetics, and medical devices. This position enforces established laws and regulations to assure that drug facilities are properly registered and licensed and that drug products are properly manufactured and stored under conditions specifically prescribed through research, testing, and scientific approvals. If violations are discovered, this position can issue product recalls and/or embargo products as necessary.

Recruitment Requirements

Knowledge, Skills, and Abilities

• Working knowledge of the rules, regulations, and practices of the pharmaceutical industry, drug manufacturing methods, and the food processing/manufacturing industry.
• Working knowledge of state and federal laws and regulations and enforcement procedures applicable to drugs, cosmetics, and medical devices.
• Working knowledge of the principles and methods pertaining to chemistry, microbiology, or related sciences.
• Ability to perform regulatory work pertaining to the manufacture, transport, storage, and sale of drugs, cosmetics, and medical devices
• Ability to understand and enforce applicable laws and regulations
• Ability to establish and maintain effective working relationships with industry and government officials
• Ability to complete required forms, records, and reports

Minimum Education and Experience

Bachelor's degree in Chemistry, Biology, Microbiology, or a related curriculum from an appropriately accredited institution and two years of experience in drug or food regulatory work; or an equivalent combination of education and experience.