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.