Regulatory Labelling Manager / Associate Director

Regulatory Professionals
North West England
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Labelling Manager / Associate Director Location: Cheshire Salary: DOE plus excellent benefits Regulatory Professionals are currently working with a top global pharmaceutical company who are looking for a Regulatory Affairs Manager/Associate Director. The role offers the opportunity to work across multiple marketed products along with pipeline products. Responsibilities will include though not be limited to: * Lead and contribute to the development if global labelling strategies * Provide labelling expertise to product labelling teams * Lead and contribute to the preparation and maintenance of EU SmPC and USPI's * Provide advice and support to operational and commercial functions in the development of innovative packaging solutions. * Prepare and maintain core labeling documents including the Core Data Sheet, and Core Patient Information Leaflets. * Develop regional regulatory strategies for product labeling in line with TA/product strategies and regional requirements. Requirements: *Regulatory Affairs labelling experience - minimum 5 years *Strategy development experience *Scientific background *Leadership skills *Life science degree and excellent communication skills Regulatory, Affairs, Manager, AD, Associate Director, Reg Affairs, RA, Pharmaceutical, Pharma, Management, leadership, strategy, oncology, Labelling, SMPC, PIL, CCDS, Cheshire, England, Regulatory, Professionals, label