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Newcastle upon Tyne, United Kingdom United Kingdom

Manager - Corporate Regulatory Affairs at Aesica Pharmaceuticals Ltd

Medical / Health Care / Pharmaceuticals

• Expert in writing CMC (Quality) Module for pharmaceutical registration dossiers (NDA/ANDA/MAA/IMPD/IND/NDS/ANDS) in accordance with the country specific regulatory requirements & submitting periodic updates. • Experience in reviewing and submitting product variations to the approved MAAs in the EU through various submission procedures like DCP, MRP and National. • Experience in writing the Type-II DMF, ASMFs (EDMF), CEPs and CEP variations. • Regulatory Intelligence: Awareness on latest regulations published by the EMA, ICH, MHRA and Federal Register (US FDA) for GDUFA and other user fee • Experience in US FDA Self Identification, Electronic drug listing and site establishment registrat...