Regulatory Affair Manager 12 Month FTC Hertfordshire, UK Competitive salary Reference: J30460 The

Regulatory Professionals
On Application
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Affair Manager 12 Month FTC Hertfordshire, UK Competitive salary Reference: J30460 The Company: This global pharmaceuticals company are looking for a Regulatory Affairs Manager to join their team to lead the development and maintenance of UK submissions. They have a major UK presence and focus on the development of new medicines across many therapeutic areas to improve the lives of patients. The role advertised will have a strong focus on the commercial side of processes. Job Description: * 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 * Formulate and influence regulatory strategy related to promoted brands Application Requirements * 4 years + Regulatory Affairs experience and degree in life sciences * Commercial awareness and business thinking * Experience providing regulatory strategy and marketing development experience * Knowledge of clinical trial approvals and maintenance of licenses for UK/ Ireland/ Malta * Strong communication and leadership 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