Responsibilities: Work as part of a global Regulatory Operations team, contributing to global filings. Lead key submissions for EU, Switzerland and Emerging Markets. Compilation and publishing of submission dossiers for Europe and the emerging markets for clinical trials, paediatrics and marketing applications. Work closely with submission content providers to advise on submission content, structure, planning and strategy. Work with publishing vendors. Regulatory submission source document review, formatting, & troubleshooting, including but not limited to, MS Office, Adobe Acrobat PDF, Acrobat Plug-ins and XML ensuring documents conform to style guide and internal/external regulations.
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