Global Labelling Lead
Proclinical are recruiting for a Global Labelling Lead to join a pharmaceutical organisation. This role is on a contract basis with the ability to work remotely from anywhere in the UK.
- Suggest the method to be followed in core labelling documents, guarantee to be in line with international regulatory methods.
- Supervise the execution of CDS updates in regional labels and oversee compliance to labelling procedures in a timely manner.
- Monitor the preparation of assisting documents for core labelling alterations, in cooperation with medical writing, guaranteeing alignment to the core labelling method and international regulatory tactic.
- Produce, preserve and update regulatory labelling processes and SOPs as well as assist with pertinent audits and inspections.
- Uphold expertise of present rules and guidelines managing international labelling actions.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Educated to a degree level in a scientific or medically linked field would be ideal.
- Demonstrable experience working within a pharmaceutical/biotechnology organisation in regulatory, which involves international regulatory labelling, EU labelling and/or US labelling.
- Know-how and comprehension of suitable guidelines, pharmacology, medicine, pharmacovigilance and drug development.
- Familiarity with document management and regulatory tracking systems.
- Capable of comprehending regulatory implications of product method with concerns to the product label, examination and practical management of affiliated impacts.
If you are having difficulty in applying or if you have any questions, please contact Ed Little at +44 203 148 8353.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.