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Manager Global Regulatory Affairs Labelling
Job Purpose: The purpose of this role is to provide regulatory leadership, governance, and expertise to a sub-category, brand, or portfolio of products to ensure successful maintenance of product labelling globally.
The individual will build collaborative relationships within Global and Regional Regulatory Affairs to provide accurate, evidence-based product information to healthcare professionals, patients, and consumers, aligned with Haleon Values.
In collaboration with departments such as Consumer Safety Sciences, Regulatory Categories, Clinical, and Medical, the role involves updating Global datasheets (GDS), creating documentation for HSB approval, supporting local PI implementation, and providing labelling expertise in RA activities.
Responsibilities:
* Update GDS according to established processes.
* Create and revise documentation for GDS approval at HSB.
* Present GDS updates and documentation for approval.
* Prepare regulatory files supporting local submissions.
* Manage country labelling differences and support CLD processes.
* Develop responses to Regulatory Authorities with support from Regional Regulatory Affairs.
* Ensure compliance with processes, policies, SOPs, and instructions.
* Provide labelling expertise for RA activities such as renewals and PBRERs.
If applicable, additional responsibilities include:
* Preparing GDS compliance metrics for GROC presentations.
* Acting as labelling SME for regulatory systems and repositories.
* Training on labelling processes for Global and Regional RA.
* Supporting process improvements and policy development.
* Representing Haleon on external task forces related to labelling (e.g., digital e-leaflet).
Education Requirements:
BA/BSc in Life sciences or related fields such as Chemistry, Pharmacy, Biochemistry, Biology, or Medical Engineering.
Interested in joining us? Discover what life at Haleon is really like at www.haleon.com/careers.
Haleon values diversity and inclusivity, fostering a respectful environment that supports all employees' authentic selves. We promote flexible working and are committed to equal opportunity employment. If you are a US Licensed Healthcare Professional, please note that Haleon may need to report expenses incurred during the interview process to comply with US transparency laws.
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