Regulatory Systems Director

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, 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 : [email protected] for any further questions