Director, Regulatory Affairs Data Standards and Governance

Role: Director of Regulatory Affairs Data Standards and Governance, focused on establishing and maintaining data standards, quality, and interoperability within regulatory systems. Responsibilities include leading data governance processes, supporting enterprise-level initiatives, ensuring compliance with external standards such as ISO IDMP, WHO, FDA, and EMA, and collaborating on the development of regulatory data platforms like Ontology services. The role involves working cross-functionally with RIM, R&D, Supply Chain, and Quality, supporting system tools like COSMOS and Hubble, and preparing for global regulatory data submission requirements. Qualifications: Bachelor's in life sciences (e.g., pharmacy, biology, chemistry), 6-8 years in regulatory affairs, R&D, or related fields, with knowledge of regulatory data standards and experience in complex global matrix environments. Preferred skills include experience with electronic regulatory submissions, data governance projects, and industry advocacy concerning IDMP. High-value specifics: focus on global regulatory data standards implementation, ISO IDMP, eCTD, structured data submissions, and industry forums. Work setup: not explicitly stated.