Principle Regulatory Consultant

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