Sign-up for the Sterling-Hoffman Life Sciences Journal to get the latest industry news and job postings.		To apply for multiple jobs at once, please select the check box beside the desired jobs on the main job category page.  Job #02560 About our client Our client is a specialty generic pharmaceutical company engaged in the formulation and commercialization of both controlled release (CR) and immediate release (IR) products utilizing their proprietary drug delivery technologies. By applying the technologies to selected generic prescription pharmaceuticals, they seek to duplicate the release characteristics of these drugs in order to manufacture and market versions that can be substituted for branded products. The company intends to develop and use their drug delivery technologies to commercialize a portfolio of generic pharmaceutical products. In the near future, they also plan to apply their drug delivery technologies to the development of proprietary branded drugs. Position Location Regulatory Affairs Manager Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Guide the regulatory strategy of the company 2) Handle ANDAs submission through approval 3) Ensure regulatory compliance by completing the appropriate filings 4) Manage various product-related tasks such as documentation of product approval, and product registration and recall as required by regulatory agencies 5) Ensure compliance with regulatory requirements 6) Design and implement regulatory strategy in order to meet the requirements of ANDA regulations, drafting and submission of regulatory documents 7) Ensure compliance with all aspects, for both – the products in development and those already launched into the market 8) Liaise with the FDA to seek guidance pertinent to the filing requirements of the company’s products 9) Lead and write the ANDA submissions and manage the daily regulatory activities 10) Review various documents such as Master Production Records, analytical methods and the stability reports submitted in ANDAs 11) Coordinate and assemble various materials for the submissions to the FDA such as drug product listings and annual reports 12) Prepare and submit ANDAs to the FDA and amend and supplement ANDAs in response to deficiency letters, federal register notices, and chemistry, manufacturing and control revisions 13) Review labeling copy and draft advertising copy to ensure compliance with government regulations 14) Review FDA submissions for completeness and accuracy Requirements 1) BA/B Sc in Life Sciences 2) 3 – 5 years of pharmaceutical experience 3) Hands-on experience in successfully completing ANDAs (traditional and CTD) with the FDA 4) Solid dosage experience 5) Ability to read, analyze and interpret common scientific and technical journals, regulatory and legal documents 6) Ability to respond to common inquires or complaints from regulatory agencies or members of the business community 7) Ability to effectively present information to top management and public groups 8) Excellent written and oral communication skills preferred
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