Regulatory Affairs Specialist

Responsibilities: Kforce has a great opportunity in the Denver area!! This person coordinates and writes submissions for FDA approval and coordinates any FDA interaction regarding a submission; serves as an internal consultant to interpret the regulations; and reviews and approves advertising and promotional materials, label copy, batch records, specification sheets and test methods. This person monitors the regulatory status of new product development and serves as regulatory affairs representative on project teams, as assigned; develops and conducts employee regulatory training, as needed or as assigned; and researches and develops SOPs for the Regulatory Affairs Department. This person also escorts government inspectors (e.g., FDA, DEA, State Board of Pharmacy, MPCA, OSHA) during inspections and facilitates the entire inspection. Also coordinates and writes any required follow-up to the inspection; and acts as corporate FDA liaison.If you are not a local candidate but are relocating, please inform me of your arrangements (i.e., date and city/state you are relocating to).Kforce (NASDAQ: KFRC) is a full-service specialty staffing firm providing flexible and permanent staffing solutions for organizations and career management for individuals in the specialty skill areas of information technology, finance & accounting, human resources, engineering, pharmaceutical, health care and scientific. Backed by more than 1,500 recruiting specialists, Kforce operates in more than 40 markets in North America. For more information, please visit our web site at