Regulatory Labelling Operations Manager
ProClinical is advertising an excellent opportunity to join an international pharmaceutical organisation as a Regulatory Labelling Operations Manager. This company specialises in developing treatments for conditions where the impact of the medicines can make an immediate and tangible difference, and provides treatments in Neuroscience, Rare Diseases and other medical sectors. The Regulatory Labelling Operations Manager will join this company's London team on a contract basis.
- Leading creation of labelling artwork for EU products, whilst collaborating with the EU Regulatory product leads.
- Managing the regulatory artworks aspects of EU product launches for an assigned product.
- Liaising with the Supply Chain team in managing packaging updates following approval, including progression of artworks via the artwork management system (SAMS).
- Overseeing outsourced linguistic review processes for products registered via the Centralised Procedure, including quality checks of EU Annexes.
- Maintaining compliance of approve texts and approved packaging.
- Liaising with EU RA LOC and key stakeholders on questions relating to artwork changes.
Skills and Requirements:
- At least 5 years' experience in Regulatory Labelling Operations or from an Artwork background.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Peter Duvall on +44 203 078 9542 or upload your CV on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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