Principle Regulatory Consultant

Regulatory Professionals
United Kingdom
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Principle Regulatory Consultant Competitive salary Location: Hertfordshire Reference: J30645 Our client, an award winning regulatory affairs consultancy, are international players with expertise in country specific regulatory requirements, finding creative solutions for any regulatory challenge. They are looking for a candidate to take responsibility of managing a portfolio of projects, including clinical development, at MAA filing stage and post-approval lifecycle management, and managing a team of regulatory professionals. The ideal candidate will have: * Project leadership experience providing strategic input, setting milestones and monitoring progress towards results * A working knowledge of scientific and regulatory environments and apply knowledge to determine solutions and solve complex problems * Technical competence analysing and understanding current and future regulatory environments and its impact on assigned products * Experience generating business from new and existing clients Responsibility will include: * Providing regulatory strategic advice on guidelines, legislation and procedures to clients on assigned projects * Preparing regulatory submissions including clinical trial applications and amendments, scientific advice requests, PIPs, MAA dossier and variations * Managing regulatory approvals procedures at national and EU level Qualifications: * Life science or pharmacy degree * Minimum 10 years' experience in EU regulatory affairs * Full UK driving license Regulatory Affairs, MAA, EU, Consultancy, Regulatory, Hertfordshire