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Regulatory Affairs Professional – EMEA Compliance

3 miesięcy temu

Warszawa, Polska ManpowerGroup Pełny etat
Job Tasks:
  • Regulatory Affairs data entry activities (e.g. track incoming data entry requests and follow up until completion in alignment with global and regional data quality standards and procedures
  • Ad hoc activities (e. g. support data owners with guidance, training, instructions on the process and requirements for maintaining data in the relevant systems
  • Align with supervisor and team members to ensure data entry backup capabilities during vacation and holiday periods 
  • Perform other related tasks as assigned by supervisor
  • Maintain compliance with all company policies and procedures
Requirements:
  • Good understanding of pharmaceutical Marketing Authorisation data and regulatory procedures (national as well as EU procedures)
  • Understanding of regulatory data planning and tracking requirements
  • Knowledge of compliance requirements and advanced process thinking
  • Good technical skills and computer proficiency
  • Proven ability to monitor multiple actions and timelines and follow up until timely completion
  • Ability to work effectively in a matrix organisation with multiple cross-functional stakeholders on global, regional and local level
  • Excellent cross-cultural communication skills in English