Regulatory Affairs Manager (Digitalization)

Your responsibilities

• • Lead a Regulatory data & application excellence team responsible for a central support of the Global Regulatory Science Directorate
  • Lay down the fundaments of digital regulatory strategy
  • Provide leadership and professional oversight for global product information & application management activities
  • Enhance operational efficiency with the continuous improvement of cross-functional and internal (RIM Team) processes, strengthen our data-driven Regulatory operation with new innovative technical solutions
  • Ensure up to date product information, keep high standards of data quality, build up a data governance framework
  • Keep up to date knowledge of new regulatory requirements, lead knowledge sharing forums on data-driven decision making and operations
  • Develop new innovative data reporting solutions. Standardisation of regular reporting processes (weekly, monthly, quarterly, annual reports).
  • Deep understanding of individual data & report needs (consultation with data owners)
  • Veeva Vault RIM knowledge base development
  • Represent leadership & professional standpoints in strategic projects and decision-making forums
  • Line-management, competency development of colleagues responsible for data & application  management

Your background

• MS; PharmD, PhD or equivalent preferred
• Innovative, data-driven, process-oriented mindset
• Excellent communication skills (hungarian and english)
• Business intelligence skills
• Line management experience
• Project management experience
• High level of problem solving skills
• Knowledge of regulatory processes (min 5 years of professional experience).
• Knowledge of pharma IT systems (Regulatory Information Management, ERP, data management tools…)

Would be a plus if you have

• Veeva Vault RIM knowledge
• Data governance knowledge

We offer

• Extensive benefits package (cafeteria, stock program, private life insurance)
• Training and development opportunities
• Medical services (Medicover)
• Company car
• Various sport and health opportunities (gym, swimming pool, AYCM)
• Challenging, responsible professional work
• Long-term employment in an innovative and secure company