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Global Regulatory Affairs Labelling Specialist

2 months ago


Weybridge, Surrey, United Kingdom Haleon Full time

Job Purpose:
The purpose of this role is to provide regulatory leadership and governance to ensure the labelling of existing products is successfully maintained globally.

In this role, the individual will build a network of collaborative relationships within Global Regulatory Affairs to ensure the provision of accurate, evidence-based product information to healthcare professionals, patients, and/or consumers for existing products.

In close collaboration with (e.g. Consumer Safety Sciences, Regulatory Categories, Clinical and Medical), the role is accountable for updating the existing Global datasheets, creating supportive documentation, and providing labelling expertise/information in RA activities.

Responsibilities:
In collaboration with stakeholders and for a sub-category, brand, or portfolio of products:

  1. Update the GDS in line with established processes and systems.
  2. Create and revise the supportive documentation required for GDS approval at HSB.
  3. Present the GDS update and supportive documentation for approval by the HSB.
  4. Plan, prepare, and deliver high-quality regulatory files supporting local submission.
  5. Manage country labelling differences and support CLD process according to agreed standards.
  6. Develop responses to Regulatory Authorities with Regional Regulatory Affairs support and key stakeholders.
  7. Ensure compliance of actions by adhering to established processes, policies, SOPs, and working instructions.
  8. Provide labelling expertise/information for RA activities (e.g. renewal, PBRERs).

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

As a Global Regulatory Affairs Labelling Specialist, you will be part of a dynamic team dedicated to ensuring the accuracy and compliance of product labelling globally. Key tasks will include updating global datasheets, creating supporting documentation, and providing labelling expertise in RA activities. Collaboration with stakeholders and adherence to established processes are essential. A degree in Life science/Pharmaceutically related science is required.