Regulatory Affairs Manager

Regulatory Professionals
United Kingdom
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Affairs Manager Competitive salary Location: Bedfordshire Reference: J29962 A researched based Biopharmaceutical Company who have a global focus of pushing the boundaries of science to deliver life changing medicines are looking for an experienced Regulatory Affairs professional. Responsibilities will include: * Delivering and maintaining licenses for UK/Ireland/Malta and driving regulatory strategies for new initiatives * Ensuring regulatory compliance for defined products and project responsibilities, including project leadership * Ensuring the delivering of clinical trial approvals and maintenance of high regulatory compliance standards for UK/Ireland/Malta through the provision of local regulatory expertise * Supporting the development of investigational and in-licensed/co-development products through contributions projects, study feasibility questionnaires and scientific advice meetings * Ensuring total compliance with GRP requirements in accordance with the local Quality Management System (QMS) SOP and all other company policies and standards Essential: * Life Sciences Degree or appropriate professionals qualifications * Operational regulatory experience in the pharmaceutical industry * Experience within a commercially aware role * Negotiation skills * Experience with the MHRA pharmaceutical, commercial, regulatory affairs, manager, GRP, QMS, Bedfordshire, UK, MHRA, commercial.