Senior Regulatory Executive

Senior Regulatory Executive Job Description Template

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


  • Communicating effectively within the function at all levels and within cross-functional project teams;
  • Planning, preparing and delivering high quality core files to agreed timelines;
  • Assist in the preparation and review of responses to requests for further information from regulatory authorities;
  • Assist in the preparation and review of dossiers for MA applications (DCP, MR or national) and ensure timely submission of applications;
  • Ensuring compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.


  • Good experience in project management;
  • Educated to degree level or above in life sciences or a related field;
  • Well-developed regulatory experience in the pharmaceutical industry;
  • Degree in life science subject with good knowledge of medicines and how they are used;
  • Understanding of the drug development process.- Good knowledge of UK directives, ICH guidelines;
  • Ability to prepare high quality regulatory dossiers.