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Job #02966

About our client Our client is an ophthalmic biopharmaceutical company based in Florida. They focus on the discovery, development and commercialization of products to meet the medical needs for the preservation of eyesight. Their corporate headquarters are based in Tampa and they boast a state-of-the-art R&D center in San Diego. With an experienced management team, a robust pipeline and a ‘can do attitude’, this is a great opportunity for the right person to join a rapidly growing company! Position Location Senior Director of Regulatory Affairs Tampa, Florida Salary Highly competitive package, commensurate with experience Responsibilities 1) Oversee all regulatory affairs activities for products (both development and commercial products) 2) Manage regulatory strategy 3) Fulfill regulatory requirements related to FDA submission compilation and maintenance 4) Comply with regulatory requirements related to commercial products 5) Provide guidance to other functional areas regarding appropriate development and commercial activities 6) Manage the electronic publishing function 7) Implement corporate strategy for electronic regulatory submissions, software selection and validation as well as execution of electronic publishing requirements 8) Oversee the electronic document management function (corporate-wide) 9) Manage corporate strategy for electronic document management in cooperation with Quality Assurance 10) Handle software selection and validation 11) Perform execution of document management function (security, permissions, structure of repository and training of employees) Requirements 1) MS/Ph. D. 2) 5+ years of pharmaceutical regulatory affairs experience 3) Small company experience preferred 4) Electronic regulatory submissions experience 5) Proficiency in computers (MS Word, Adobe Acrobat) 6) Knowledge of eCTD requirements 7) Excellent communication and interpersonal skills 8) Self-motivated team player