Regulatory Executive: Labelling
- Weybridge, Surrey (GBR)
- £300 - £335 Per Day
- 9 Months
- Start date: ASAP
- Ref: GSK0JP00087819
- Regulatory Affairs
- sops
- labelling
- compliance
- documentation
Job description
Posted 09 February 2021
Regulatory Executive: Labelling
Role is initially working from home
Description:
- Working with the Labelling Team and in collaboration with all relevant stakeholders (e.g. Regulatory Categories, SERM, Clinical and Medical),
- Support the update/maintenance of the Global Data Sheet (GDS) in line with established GSK processes and systems
- Help during creation and review of the supportive documentation required for GDS approval at applicable review forums
- Support the presentation of GDS update and supportive documentation for approval by applicable review forums
- Help planning, preparing and delivering high quality regulatory files supporting local submission
- Manage and support country labelling difference (CLD) process according to SOP.
- Help with development of responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders
- Ensure GDS compliance is maintained by adhering to established processes, policies, SOPs and working instructions
