Our Client a global CRO is recruiting for Regulatory Affairs Specialist. This role based in the South East will provide regulatory advice and act as liaison with internal and external clients in the provision and marketing of regulatory affairs services.
- Oversee regulatory submissions for assigned projects/countries/sites, which may include completion of submissions or notifications, as required
- Provide advice and support to the project team for regulatory aspects of the projects
- Provide regulatory support as needed for drafting applicable study documents, including the protocol and informed consent form.
- Investigate proactively and capitalize regulatory information collected throughout studies and maintain Regulatory database accordingly
- Working to timelines, budgets and regulatory requirements for each project.
- Significant regulatory affairs experience preferably with global understanding of clinical trials
- Ideally candidates will have a degree (or equivalent)
- Knowledge and understanding of ICH and global regulatory guidelines, preferred
- Experience managing and leading projects
In return for meeting the above criteria, the successful candidate will be rewarded with a very competitive basic salary.
Elevate Pharma is a specialist Life Science Recruiter and this vacancy is just one of a number of positions that we currently have available in this sector.