Senior Regulatory Affairs Manager

Senior Regulatory Affairs Manager Job Description Template

Our company is looking for a Senior Regulatory Affairs Manager to join our team.


  • Keep up to dare with relevant regulatory intelligence and ensure that this is communicated appropriately across the company;
  • Matrix and Team Management Provides feedback, sets clear tasks and objectives and coaches team members on a periodic basis;
  • Lifecycle Management Contributes to the planning, execution, and assessment of product life cycle management activities and strategies ;
  • Interfacing with Authorities Contributes to, and implements, strategy for interactions and negotiations with health authorities;
  • Ensure that marketing authorisations (MAs) are maintained in compliance with relevant regulatory requirements and business priorities.


  • GMO;
  • MAAs;
  • CTAs;
  • Regulatory Affairs Senior Manager;
  • Ideally, experience with EU Scientific Advice/PIPs or Orphan Drugs, as well as some experience in Neuroscience therapy area;
  • Background in EU Regulatory activities, specifically with Clinical Trials;
  • Good organisational skills, including efficiency, punctuality, and collaboration in a team environment;
  • Good interpersonal skills, including communication, presentation, persuasion, and influence;
  • Demonstrable multitasking, project management, and execution skills;
  • Regulatory strategy experience and strong strategic thinking skills;
  • Desirable: some experience in neurosciences therapy area, development of Global Paediatric strategy(ies);
  • Supporting EU RA activities – specifically two compounds in Phase III;
  • Close interactions with US-based GRL’s and cross functional teams globally;
  • BSc/MSc in relevant field;
  • Experience with EU scientific advice, EU Paediatric Regulatory procedures and Orphan drugs.