10 days ago

Regulatory Submissions Publisher


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Regulatory Submissions Publisher

HEMEX is a biotech consulting company supporting pharmaceutical start-ups and spin-offs around the globe. We are looking for an experienced Regulatory Submissions Publisher to join our team in Liestal. The Regulatory Submissions Publisher will be responsible for preparing and publishing various regulatory documents, ensuring compliance of submissions to global health authorities within required timeframes. Principal Responsibilities: ? Preparing, compiling and publishing eCTD submissions ? Formatting of regulatory MS Word documents (Module 1 to Module 5) ? Compliance check of source documents ? Prepare PDFs as per regulatory requirement using publishing plug-ins ? Coordinate with regulatory team members ? Performing external hyperlinking and validation of the submission. ? Assist with other Regulatory Operations activities, as assigned Qualifications: ? Experience in eCTD publishing and filing with mainstream publishing tools ? Knowledgeable in CTD/eCTD structure and requirements and a good understanding of submission requirements for global submission types (e.g. IND, BLA, MAA, NDS, CTA, PSUR etc.) ? Working experience in publishing and compilation of eCTD submissions for US and EU filings is required and experience publishing electronic submissions in other regions is desirable. ? Knowledge of Microsoft Office suite, Adobe Acrobat and plug-ins, electronic document management systems, and other relevant tools. Experience and knowledge of SharePoint technology is desired ? Broad office software knowledge (MS Word, Adobe Acrobat, Acrobat Plug-ins, Document Management Systems, Excel) ? Strong attention to detail, good organization, communication, and collaboration skills ? Working knowledge of global regulatory practices and electronic submission guidelines ? Able to work independently ? Able to work overtime at peak times We offer: ? Join a highly motivated and skilled team ? Competitive remuneration package ? Pleasant working environment in a dynamic organization ? Flexible working hours and location including home office Please send your CV in English, including all supporting documents, by e-mail to info@hemex.ch Job Ad Regulatory Publisher.pdf