xEVMPD/IDMP Systems Manager
Job details
Pharmaceutical Regulatory Information Manager (Senior - Principle Level). (Can only hire within: Germany, Austria, Spain, Poland, UK, Netherlands and Croatia - Applications outside these regions will be rejected from the hiring process) - The role is Fully remote within these countries. DNA Life Sciences is seeking a Regulatory Information Manager to lead high-impact projects in collaboration with major biotech and pharmaceutical companies. This role offers the opportunity to work on cutting-edge initiatives that drive regulatory strategy and compliance for leading industry players. Profile Experience • 3-8+ years of experience in the Pharmaceutical Industry, you have gained expertise in Regulatory Operations and Regulatory Information Management. • You are a visionary when it comes to driving digital transformation in Life Sciences, enabling data-driven regulatory submissions, and automating processes. • You have a profound understanding of regulatory processes and data which allows you to connect with other functional areas within the pharmaceutical value chain. • You are an expert in data management, including Data Governance and Master Data Management. • You have practical experience with xEVMPD and IDMP and possess comprehensive knowledge of relevant guidelines, such as the EU IDMP Implementation Guide. • you have experience in implementing and operating RIM systems, as well as developing and executing data migration strategies. • You have an affinity to business and technology which enables you to translate between both effectively. • You have a positive experience in ontologies and semantic data modelling. Please reach out to: shaun@dnalifesciences.co.uk for any further questions
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