Job description Posted 25 November 2021
12 Month Contract
Brentford, London - Flexible remote working available
Up to £40 per hour via Umbrella inside IR35
- Role involves supporting delivery of global registrations of new products/line extensions and lifecycle maintenance in the EU.
- It involves working other functions to confirm requirements, deliverables and agree timelines and plan/implement delivery strategy for Initial registrations/line extension submissions to markets globally in which GSK does business.
- Successful candidate will ensure that dossiers are prepared in compliance with Regulatory Authority regulations and guidelines and in line with GSK SOPs and working practices.
- They will also plan and ensure delivery of lifecycle activities for products registered in EU (for example variations, periodic benefit risk evaluation reports (PBRER) and range of submissions (eg scientific advice and paediatric investigation plans) supporting R&D projects in development ensuring delivery to agreed timeframes and in compliance with GSK process and policy as they apply to the role.
- Experience with Regulatory Affairs in the Drug development environment
- Experience supporting new registrations in EU and global markets and also lifecycle markets in the EU would be an advantage