Pharmaceutical Regulatory Information / Systems Director
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
* 5-8+ years of experience in the Pharmaceutical Industry, with expertise in Regulatory Operations and Regulatory Information Management.
* A visionary in driving digital transformation in Life Sciences, enabling data-driven regulatory submissions, and automating processes.
* Profound understanding of regulatory processes and data, facilitating effective collaboration across the pharmaceutical value chain.
* Expertise in data management, including Data Governance and Master Data Management.
* Practical experience with xEVMPD and IDMP, with comprehensive knowledge of relevant guidelines such as the EU IDMP Implementation Guide.
* Experience in implementing and operating RIM systems, as well as developing and executing data migration strategies.
* Ability to translate between business and technology effectively.
* Experience with ontologies and semantic data modelling.
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