Manager Global Regulatory Affairs Labelling
Job Purpose:
The purpose of this role is to provide regulatory leadership, governance, and expertise to one sub-category or a brand or a portfolio of products such that the labelling of existing products is successfully maintained globally.
In this role, the individual will build a network of collaborative relationships within Global and Regional Regulatory Affairs to ensure the provision of accurate, evidence-based product information to healthcare professionals, patients, and/or consumers for existing products according to Haleon Values.
In close collaboration with (e.g. Consumer Safety Sciences, Regulatory Categories, Clinical and Medical), the role is accountable for updating the existing Global datasheets (GDS), creating the supportive documentation to support both HSB approval and local PI implementation (regulatory files, CLD, response to questions), and providing Labelling expertise/information in RA activities.
Responsibilities:
In collaboration with all stakeholders (e.g. Regulatory Categories, Consumer Safety Sciences, 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 HSB.
* Present the GDS update and supportive documentation for approval by the HSB.
* 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.
* Support continuous improvement of labelling process and direct new policy or pioneer new processes or improvements to Haleon's competitive advantage.
* May act as Haleon representative to external groups on specific task forces within labelling expertise (e.g. digital e-leaflet).
Education Requirements:
BA/BSC Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)
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