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Job #03486

About our client Our Client is a global pharmaceutical company based in Florida. They focus on the development of generic therapeutics. The company has premier investors, an experienced management team, a robust pipeline and an empowering corporate culture that is focused on the professional development of it's employees. Position Location Regulatory Affairs Manager Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Lead and write the ANDA submissions and manage the daily regulatory activities 2) Review various documents such as Master Production Records, analytical methods and stability reports 3) Coordinate and assemble various materials for the submissions to the FDA such as drug product listings, annual reports 4) Review FDA submissions, for completeness and accuracy, prepare and submit ANDA's, amend and supplement ANDA's in response to deficiency letters, federal register notices, chemistry, manufacturing and control revisions 5) Review labeling copy and draft advertising copy to assure compliance with government regulations 6) Must have the ability to read, analyze and interpret common scientific and technical journals, as well as regulatory and legal documents Requirements 1) Minimum of 3-5 years previous experience specifically in a hands-on role and successfully completed ANDAs (traditional and CTD) with the FDA 2) Solid working knowledge of regulatory submissions 3) Exceptional interpersonal, organizational, and leadership skills as well as excellent written and verbal communication skills 4) Awareness of the "regulatory environment" at the FDA to anticipate and address requirements for product development 5) Solid dosage experience a must