Company: Regulatory Professionals
Closing Date: 30 Dec 16
Salary (£): On Application
Global Labelling Contractor Rate: Highly Competitive Location: Hertfordshire Duration: 6 months (Strong likelihood of extension)
Global Labelling Contractor
Rate: Highly Competitive
Duration: 6 months (Strong likelihood of extension)
Regulatory professionals have been tasked by an esteemed international pharmaceutical firm to source an experience Regulatory Affairs Global Labelling Coordinator.
This is a leading pharmaceutical company of which opportunities to operate with them on contract basis do not come often, if you would like to be considered please contact Asiel as soon as you can.
For this position, the successful professional will be proficiently capable of facilitating the development, review, approval and maintenance of the Company Core Data Sheets for assigned products.
Enable the development, review, approval and maintenance of the Country Product Information and CPI components for assigned products. In addition to representing the Global Regulatory Affairs Global Labelling Group on project teams.
The remit will also involve, assisting in the coordination of cross-functional teams in the development and lifetime maintenance of the SmPC for assigned products/projects. This includes QC, proofing and formatting of documents, coordinate review, approval and implementation of approved SmPC.
The optimal candidate will l have a background that encompasses the following:
*Exposure to both Local and global regulatory labelling environments
*Proven experience in Regulatory, R&D or related area, with some or all of this experience in labeling.
*A solid working knowledge of drug development process and EU labeling guidelines.
*Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
*Degree or higher in a life science subject or equivalent.
*Knowledge of and experience with Asia and other markets is highly desirable.
*Be eligible to work in the UK
Keywords: labelling, labels, Artwork, CCDS, Company Core Data Sheets, SmPC, SPC, Summary of Product Characteristics, EU, AIPAC, MENA, Reg Affairs, US, EU, UK, Regulatory Affairs Project Manager, Global Labelling, Freelance, Contract
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