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Work Background
InceptuaGlobal Regulatory Affairs Manager EAP
Aug. 2024
CencoraRegulatory Affairs Associate
Mar. 2022 - Aug. 2024Weybridge, England, United KingdomResponsible for Regulation of Artwork for Medical devices of the Alvita brand. ~700 products in 7 countries, UK, France, Spain, Turkey, Germany, Italy and Portugal.
BAP PharmaRegulatory Affairs Officer
May. 2021 - Mar. 2022Responsible for import and export regulations of unlicensed medication world wide and also medical information. Part of the Medicine Access devision.
AbbVieRegulatory Labelling Project Manager EU
Oct. 2020 - Mar. 2021Maidenhead, England, United KingdomEU Labelling project manager has assigned products for which they are responsible for End to End labelling. Therefore, maintains EU SmPCs for marketed products and EU PILs for initial approvals and updates to marketed products approved by the Centralized or Mutually Recognised Procedure in the EU/EEA. In addition is responsible to input content and layout per EMA requirements for mock-ups and production artwork.
PfizerManager Regulatory affairs (Translation Oversight Manager)
Jan. 2012 - Sep. 2013Walton Oaks & Sandwich, UK• CP, Centralised Procedure: Project managing translation of European CP products in 23 languages for updates of labels or new MAA. Liaise between Pfizer Country Officer (PCO) in each country and EMA during CHMP opinion. Using Eudralink.and GDMS to provide all drafts. Quality and formatting checking all translations according to EMA’s QRD guidelines.
Worked closely with the Labelling and artwork specialist and Head of translation management. We worked under Head of international labelling group. Also worked closely with strategist, EU lead for some of Pfizer’s high profile CP products.
• Croatian PALC project: Croatia’s transition into the EMA upon its entry into the EU. Updating each CP products (24 Pfizer products) with the Croatian language, Hrvatski.
Liaising with Croatian PCO’s, EMA and Health authority of Croatia (HALMED). Worked closely with Director and project lead for Croatia.
• GiO (Global integrated Operation) of national medical information labels: Project managing translations of European labels first 6 months, then moving over to managing translations for AfMe/EME (Africa, Middle East/ emerging markets of Europe). Worked closely with Director for the Arabic language countries and Project involved centralising the translation of labels through the use of one centralised translation agency rather than using separate agencies in each country. Furthermore: setting up strategy and process flow charts for these new procedures; maintaining awareness of the quality and regulation requirements of each country. • Translation vendor coordinator: Worked closely with translation vendor Lionbridge and LUZ which where allocated to work on my responsible countries. Worked closely with HLM’s (Hub Labeling Managers) under Labeling lead. Ensured all initiated labelling jobs provided by HLM’s where translated and delivered back to them in time.
Durbin PlcPharmaceutical Technical Advisor
Nov. 2010 - Jan. 2012Sourcing and researching UK-unlicensed and named patient medications from all over the world. obtaining permission from the MHRA (UK Authority) to import the US licensed product into the EEA. Go through the process of providing information and certification to the authorities in the UK, before receiving permission and then treat supply to other EEA pharmacies and hospitals as wholesale dealing.
HCA Hospitals, LondonPharmacy Technician
Jun. 2009 - Nov. 2009Participated in preparation of parenteral cytotoxic chemotherapy in accordance with written procedures and involved in physical and environmental monitoring of aseptic unit; provided a dispensing service to both in and outpatients as well as patient counselling; provided an efficient, accurate and economical ward top-up service according to hospital protocol. During this work period, I was awarded extensive training opportunities for my hard work. I achieved an NVQ 3 in pharmacy in May 2009 with The National Pharmacy Association
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