The Senior Regulatory Writer will have the opportunity to work with well-known, innovative pharmaceutical companies across a range of therapy areas.
Responsibilities:
* Plan and deliver regulatory submissions on behalf of pharmaceutical clients
* Prepare clinical regulatory documents across multiple therapy areas
* Evaluate scientific data
* Work on projects independently as well as group projects
Qualifications:
To apply for this role as Senior Regulatory Writer, our client is hoping for someone with the following skills and experience:
* Ample regulatory writing experience within a pharmaceutical company, CRO or Consultancy
* Experience writing clinical regulatory documents to a high standard
* Strong understanding of clinical development and ICH guidelines
* Experience authoring regulatory documentation such as CTD modules, response documents, and regulatory briefing documents
* Degree educated in life sciences / pharmaceutical science
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