Labelling Hub
- Home Counties
- Contract
- Drug Safety / Pharmacovigilance
This vacancy has now expired
Are you looking for the opportunity to work alongside a global pharmaceutical organisation in UK? 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.
The Labelling Hub ETW will be responsible for regulatory activities pertaining to labelling updates for specifically South Africa / Africa & some potential support with other countries globally, according to internal procedure and legislation applied to this country under her/his responsibility.
Labelling Hub Responsibilities:
- Provide Subject Matter Expert support to the Global Labelling Hub and Global Compliance Director, and other Stakeholders with initiatives which impact labelling activities within the determined region and country/ies.
- 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.
- 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.
We have worked together with Quanta for seven years now and have always received a professional service. Quanta’s speciality certainly lies within their technical sourcing abilities and they have met our demanding requirements time and time again. Coupled with this are the integrity of Quanta’s people and their ability to deliver.
Global Pharmaceutical firm
Once again can I via you recognise the superb support I was given before, during and after this short contract. The support, was as usual professional and every friendly.
QA Specialist
I have always received a highly professional & personable service from the team at Quanta. They listen carefully to the specific requirements of available roles and work tirelessly to supply a pool of potential candidates and make the hiring and contract renewal process an easy activity to manage.
Global Pharmaceutical firm
Save as job alert
Similar Jobs
Salary
Competitive
Location
Greater London
Salary
Competitive
Sector
Drug Safety / Pharmacovigilance
Job type
Contract
Location
London
Description
Regulatory Affairs Manager - Greater London - Life Science - 12-Month Contract Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Regulatory Affairs
Reference
34089
Expiry Date
01/01/0001
Author
Kathryn TaylorAuthor
Kathryn TaylorSalary
Competitive
Location
East Anglia
Salary
Competitive
Sector
Drug Safety / Pharmacovigilance
Job type
Contract
Location
East Anglia
Description
Senior Regulatory Manager - Pharmaceuticals - 12-Month Contract Our client, a globally recognised pioneer in Biotechnology, are recruiting for the position of Senior Regulatory Manager. A leader
Reference
34156
Expiry Date
01/01/0001
Author
Kathryn TaylorAuthor
Kathryn TaylorSalary
Competitive
Location
Central London
Salary
Competitive
Sector
Drug Safety / Pharmacovigilance
Job type
Permanent
Location
London
Description
Regulatory Affairs Specialist - London - 12-Month Contract Do you want to be part of a forward thinking global pharmaceutical client who have facilities in over 60 countries worldwide? Then this
Reference
33886
Expiry Date
01/01/0001
Author
Kathryn TaylorAuthor
Kathryn TaylorInsights
Send us your CV
Our candidates are the cornerstone of our organisation and we are always looking to connect with new professionals who are seeking their next contract assignment or career opportunity.
Kathryn
I manage this role.