Regulatory Affairs Manager

Recruiter
Regulatory Professionals
Location
United Kingdom
Posted
27 Sep 2017
Closes
03 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
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.