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.