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Labelling Hub

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Competitive
  1. Drug Safety / Pharmacovigilance
14-09-2023
32014
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Labelling Hub – Pharmaceuticals - Hertfordshire

Are you looking for the opportunity to work alongside a global pharmaceutical organisation in Ireland’s picturesque capital? Our esteemed client is looking for a Labelling Hub to join their team in their existing manufacturing facility in Hertfordshire.

The facility is a responsible for tablet manufacturing (OSD) and secondary packaging (blister packing and bottle primarily for tablets and capsules), and our client is looking for a Labelling Hub to help maintain manufacturing operations.

Labelling Hub Responsibilities:
  • Point of Contact to Global Labelling Team regarding countries/licenses under her/his responsibility
  • Reports on agreed key performance indicators for set region.
  • Onboards and manages regional assigned labelling associates.
  • Communicate clearly issues and resolutions to peers and subordinates in a meaningful way.
  • Ensure local labelling text is prepared right first time and on-time according to agreed company procedures and objectives.
  • Support regional labelling team members with health authority questions, requests for further information, preparation, and review of labelling documents prior to submission.
  • Advise Global Labelling Hub and Global Compliance Director regarding any deficiencies or issues.
  • Ensure that supportive documents, not limited to Core Data Sheet or other Reference Label such as USPI, SmPC are obtained in a timely manner to the countries according to local legislation.
  • Arranges and updates Local Labelling texts above market on behalf of all impacted markets to ensure their conformity with internal procedures and local legislation.
Required Skills:
  • Bachelor’s degree in science, Medicine or Pharmacy, or master’s degree, PharmD, or PhD in Science, Medicine, or Pharmacy.
  • Global Labelling and Regulatory experience.
  • Regulatory experience working with Regional Heath Authorities and in-depth Regional Labelling knowledge.
  • Highly developed interpersonal, presentation and communication skills with advanced local languages:  Afrikaans, French / Arabic and English language capability.
  • Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
  • Understand GLC requirements/ processes and EU/ US regulatory requirements.
  • The ability to influence effectively in a matrixed, cross functional team environment.
If this role is of interest, please apply now.

The candidate must have the rights to work in the location stated in the job advert.

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