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Regulatory Affairs Data Lead

vor 2 Wochen

Basel, Basel-Stadt, Schweiz Novartis Farmacéutica Vollzeit

Job Summary

This role is responsible for setting the overall platform strategic direction, establishing and enforcing data governance across all functions to drive harmonization and continuous improvements to the data landscape on data quality and maturity as well as emerging requirements.

About the Job
  • Develop and maintain a deep understanding of regulatory requirements and structured data submissions standards and initiatives.
  • Collaborate with business, IT, and other stakeholders to develop and define project scope, objectives, and interdependencies for projects.
  • Effectively manage demands for data services and operational support arising from various functions within Regulatory Affairs.
Key Responsibilities
  • Establish clear strategic thinking, prioritization, maintaining awareness of global patient and business impact.
  • Represent the RA department in cross-functional data governance boards and line function management meetings.
  • Develop and nurture relationships with other functions and external partners to ensure the expansion of data solutions across the portfolio and alignment to the development and enterprise data strategy and roadmap.
Essential Skills and Qualifications
  • 8+ years of relevant industry experience.
  • Bachelor's degree, master's or commensurate experience; Advanced degree in life science, pharmaceutical, technology or data science preferred.
  • Matrix / cross-functional leadership experience preferred.
  • Strong understanding and direct relevant experience with the data Strategy and management landscape of pharmaceutical regulatory affairs and regulatory information management.