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Bronagh Brolly

Senior Regulatory Affairs Executive
Belfast, Northern Ireland, United Kingdom

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regulatory affairs medical writing strategic outsourcing development global regulatory intelligence regulatory strategy chemistry manufacturing controls authoring module 23 quality module 3 quality drug master files post approval submissions preparation of cmc dossiers annual renewals ctd data collection gap analysis remediation due diligence lenc small molecules large molecules vaccines biosimilars gcp gmp quality assurance audit preparation benchmarking strategic consultancy market expansion infrastructure & resources operational optimization

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