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.
- 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.