Director of Quality and Regulatory Affairs - Weybridge, Surrey, United Kingdom - Haleon

Haleon Weybridge, Surrey, United Kingdom

2 weeks ago

Description

Manager Global Regulatory Affairs Labelling

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.

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.

Regulatory Categories, Consumer Safety Sciences, Clinical and Medical) and for a sub-category, brand or portfolio of products:
Plan, prepare and deliver high quality regulatory files supporting local submission.
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.

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).
BA/BSC Life science/Pharmaceutically related science (Chemistry, Pharmacy, Biochemistry, Biology, Medical Engineering)

We're striving to create a climate where we celebrate our diversity in all forms by treating each other with respect, listening to different viewpoints, supporting our communities, and creating a workplace where your authentic self belongs and thrives.

We believe in an agile working culture for all our roles.

We want to have an opportunity to consider a diverse pool of qualified candidates and this information will assist us in meeting that objective and in understanding how well we are doing against our inclusion and diversity ambitions.

All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, Haleon may be required to capture and report expenses Haleon incurs, on your behalf, in the event you are afforded an interview for employment.

This capture of applicable transfers of value is necessary to ensure Haleon's compliance to all federal and state US Transparency requirements.

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