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Job #03456

About our client Our client is a rapidly growing specialty pharmaceutical company that is focused on the development and commercialization of women’s health and gastroenterology products. The company has an experienced management team, excellent revenue momentum and offers equity to all employees. This is a unique opportunity for someone that wants to put their drive and to work for an entrepreneurial organization that rewards initiative with true ownership Position Location Regulatory Affairs Manager Atlanta, GA Salary Highly competitive package, commensurate with experience Responsibilities 1) The position is for manager of regulatory affairs including ad promo, pharmacovigilance and quality assurance 2) The individual will report directly to the chief medical officer and will be responsible for assuring that the company is compliant with all relevant FDA regulations and guidance pertinent to dietary supplements, medical foods and OTC medications 3) All manufacturing and pharmacovigilance is outsourced, but the individual will be responsible for assuring quality of products and expedited reporting of any relevant safety information to the FDA Requirements 1) 5+ years experience of working in OTC/dietary supplements area 2) Hands on experience in the OTC/dietary supplements regulatory environment 3) An educational background in biological sciences or healthcare delivery 4) Demonstrated ability to be self-motivated. Able and willing to work in an entrepreneurial environment 5) A “can do” attitude