The Role
The Principal Regulatory Writer will be responsible for leading the planning and delivery of regulatory submissions and other large regulatory projects in a concise and accurate manner.
1. Plan and deliver regulatory submissions on behalf of pharmaceutical clients
2. Prepare clinical regulatory documents across multiple therapy areas
3. Evaluate scientific data
4. Work on projects independently as well as group projects
You
To apply for this role as a Principal Regulatory Writer our client is hoping for someone with the following skills and experience;
5. Regulatory writing experience
6. Experience writing clinical regulatory documents to a high standard
7. Strong understanding of clinical development and ICH guidelines
8. Experience authoring regulatory documentation such as CTD modules, response documents and regulatory briefing documents
9. Degree educated in life sciences / pharmaceutical science