Job description Posted 03 May 2022

Senior Regulatory Executive

8 Months


£500p/d via Umbrella

Role Brief:

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).

If applicable,

• 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).