Labelling Hub

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.

To view Quanta's privacy policy, please visit our website