Regulatory Site Manager

Regulatory Professionals
13 Nov 2017
16 Nov 2017
Contract Type
Full Time
Regulatory Site Manager
9 month contract
Ideal location if you are based in Cambridgeshire, Suffolk, Essex or Hertfordshire
Attractive Rate
Immediate start

A leading pharmaceutical organisation seeks a Regulatory Site Officer to join their team on a 9 month contract basis. As specialists in rare diseases, multiple sclerosis, immunology and oncology, you will be responsible for the review and approval of cGMP regulatory reports and protocol submissions. The ideal candidate will be able to start immediately and demonstrate knowledge of working within quality management systems, cGMP and compliance.

Responsibilities include;
- Reviews and approves cGMP or reulgatory reports/protocols/ submissions
- Analyse complex regulatory issues and processes
- Sign off for key regulatory and cGMP documentation from site
- Participate in auditing of third parties from regualatory and cGMP perspective

Candidate Requirements
- Understanding of drug development process and compliance
- Regulatory CMC experience
- Previous experience with quality management systems, cGMP and compliance
- 1 month notice or less

Regulatory, pharma, CMC, eGMP, quality management systems, compliance, regulatory reports, protocols, Hertfordshire, Norfolk, Suffolk, Essex, Cambridgeshire, Regulatory Site Officer, Regulatory Officer