Senior Regulatory Executive
£500p/d via Umbrella
In collaboration with all stakeholders (e.g. Regulatory Categories, SERM, Clinical and Medical) and for a sub-category, brand or portfolio of products:
• Update the GDS in line with established processes and systems.
• Create and revise the supportive documentation required for GDS approval at CHSLC.
• Present the GDS update and supportive documentation for approval by the CHSLC.
• Plan, prepare and deliver high quality regulatory files supporting local submission.
• Manage country labelling differences and support CLD process according to agreed standards.
• Develop responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders.
• Ensure compliance of their actions by adhering to established processes, policies, SOPs and working instructions.
• Provide Labelling expertise/information for RA activities (e.g. renewal, PBRERs).
• Prepare GDS compliance metrics for presentation at GROC and complete follow up activity when required to ensure timely implementation of GDS updates in local markets.
• May act as labelling SME to support successful implementation of Regulatory Information Management systems, and act as SME for other regulatory systems and repositories as required.
• Provide training on labelling processes for Global and Regional RA.
• Collaborate with RA Compliance to support continuous improvement of labelling process and direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
• May act as GSK CH representative to external groups on specific task forces within labelling expertise (e.g. digital e-leaflet).