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Job #03198

About our client Our client is a global pharmaceutical company based in Sunrise, 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 its employees. Position Location Regulatory Affairs Manager Sunrise, Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Take a pivotal role in guiding the regulatory strategy of the company 2) Oversee the designing and implementation of regulatory strategy to meet the requirements of ANDA regulations 3) Draft and submit regulatory documents as well as ensure compliance with all aspects (for both the products in development and those already launched into the market) 4) Liaise with the FDA to seek guidance pertinent to the filing requirements of the company’s products 5) Lead and write the ANDA submissions and manage the daily regulatory activities 6) Review various documents such as master production records, analytical methods and stability reports 7) Coordinate and assemble various materials for the submissions to the FDA such as drug product listings, annual reports, etc. 8) Review FDA submissions for completeness and accuracy 9) Prepare and submit ANDAs 10) Amend and supplement ANDAs in response to deficiency letters, federal register notices, chemistry, manufacturing and control revisions 11) Review labeling copy and draft advertising copy to ensure compliance with government regulations Requirements 1) Minimum 3 – 5 years of experience in a hands-on role and experience in successfully completing ANDAs (traditional and CTD) with the FDA 2) Solid dosage experience 3) In-depth working knowledge of regulatory submissions 4) Awareness of the ‘regulatory environment’ at the FDA to anticipate and address requirements for product development 5) Superb communication skills (written and verbal) 6) Exceptional interpersonal, organizational and leadership skills 7) Ability to read, analyze and interpret common scientific and technical journals, as well as regulatory and legal documents