Ed Porter Email & Phone Number

Medical, Regulatory. Quality, Safety, Concept, Feasibility, Regulatory Strategy, Clinical Development and Investigation, Non-Clinical, Bioequivalence, New Drug, Abbreviated Drug, Device, Advertising and Promotion, Labeling, Regulatory Operations, Chemistry Manufacturing and Controls. Health Authority collaboration. Global experience. Experience: -- IND, MAA, NDA, ANDA, DMF, ASMF, Solid Oral, Solution Oral, Aseptic and Terminally Sterilized Injections, Dose Preparation Kits, Device, Combination Products, -- Global / Local Quality and Regulatory Strategies for New Chemical Entity and Line Extension Products, -- Health Authority Communications, Collaborations including under PDUFA, GDUFA, and MDUFA, and Issue Resolution -- Quality and Regulatory Operations, Advertising and Promotion, Labeling Operations, -- Due Diligence, Divestiture, Acquisition, Organization Turn Around, Restructure, and Global Build Back-- RA leadership of Global Market Justification process for NCE and Line Extension submission-- Management of potential RA and QA Negative Cost Variables against market. -- Past positions as Head of US RA, Head of Global RA, and Head of North America -- RA Management of OUS Quality Systems and Regulatory Operations, -- Management of Corporate RA Department Budget and Country level Budgets. Curium - formed by uniting Mallinckrodt Nuclear Medicine and IBA Molecular. Curium is a world-class nuclear medicine solutions provider with over 50 years of industry experience. We are proud to service over 14 million patients worldwide each year and strive to provide best-in-class quality products and exceptional, reliable service.

Listed skills include Regulatory Affairs, Regulatory Submissions, Fda, Pharmaceutical Industry, and 18 others.

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  Southern Illinois University

  Biology