Regulatory Affair Manager 12 Month FTC

Regulatory Professionals
United Kingdom
On Application
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Affair Manager 12 Month FTC Location: Hertfordshire Salary: competitive Reference: J29975 I am currently working with one of the top global pharmaceutical company who are looking for a Regulatory Affairs Manager. This is offering a broad range of exposure across many Regulatory Affairs therapeutic areas. The ideal candidate will provide regulatory expertise and lead the development and maintenance of UK submissions with a strong focus on commercial side of the processes. Candidate Responsibilities: - Deliver and maintain licences for UK/Ireland/Malta including driving regulatory strategy - Ensuring regulatory compliance for defined product and project responsibilities - Timely delivery of submission approvals and maintenance of high regulatory compliance standards for UK/Ireland/Malta - Support the development of investigational and in-licensed products through valued contributions to projects, study feasibility questionnaires and scientific advice meetings - Full compliance in line with the local Quality Management System - Support of Commercial Teams through contributing to objectives, promotional copy approval process - Provide strategic regulatory advice related to promoted brands including competitor's intelligence and project managing of commercial strategic value - Formulate and Influence Regulatory Strategy Candidate Requirements: *Regulatory Affairs experience - minimum 4-5 years *Regulatory strategy and marketing development experience *Commercial awareness and business thinking *Scientific background highly desirable *Leadership skills *Life science degree and excellent communication skills : Regulatory, Affairs, Manager, Marketing, Reg Affairs, RA, Pharmaceutical, Pharma, Management, leadership, strategy, oncology, submission, CTA, MAA, UK, Ireland, MHRA, Malta, Hertfordshire, London, Buckinghamshire, England, Regulatory, Professionals