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AJ Acker

SVP, Regulatory Affairs, Quality Assurance & Pharmacovigilance
Annexon Biosciences

Senior pharmaceutical executive with over twenty-five years of experience in the pharmaceutical industry. Strategic, hands on, result oriented leader with a passion for developing products in rare diseases and serious unmet needs. Successful recent achievements in efficient global regulatory development strategies, negotiations and approvals with FDA, EMA and PDMA. Experience in building lean, high performing Regulatory Department. Extensive knowledge developing product candidates including INDs, CTAs, IMPDs, NDAs, BLAs, Breakthrough Therapy designations, Orphan designations, Briefing Packages and Pediatric plans. Direct experience negotiating with regulatory authorities including FDA, EMA, PMDA and others throughout EU and Latin America; including recent approval of NDA and MAA for Orphan designated product.

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