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Greater San Diego Area United States

Senior Manager Regulatory Affairs Operations

Medical / Health Care / Pharmaceuticals

• Performed Gap analysis on outstanding issues/questions/requests to ensure compliance and closed loops for BLA success • Management of vendors, junior staff and consultants • Implemented Companywide Format Guide and SOPs into the Regulatory Department • Assisted in writing Orphan Drug Designation Application for UK (MHRA) and US (FDA) • Converted us from old IND Format in paper to eCTD ready • Liaise with FDA on program strategy to facilitate the prompt review and approval of applications • Cultivate regulatory environment and communicate priorities to stakeholders. • Compilation and management of necessary documentation for regulatory submissions including correspondenc...