Hub Labelling Specialist

Overall Job Purpose:

An excellent opportunity has arisen for an experienced Labelling specialist to join my client on an initial 12 month contract, which falls inside IR35.

Within this role you will be responsible for regulatory activities pertaining to labelling updates for South Africa / Africa & some potential support with other countries globally - previous SAHPRA (South African Health Products Regulatory Authority) experience is essential! You will also provide Subject Matter Expert support to the Global Labelling Hub and Global Compliance Director, and other Stakeholders.

Main Accountabilities:

• 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.
• 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.
• Manage all labelling variations through the Regulatory Information Management System and Trackwise Change control environment as needed to show compliance to global submission timelines and valid reason for delay.

• Strong SAHRA (South African Health Products Regulatory Authority) is essential.
• 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.