Regulatory Manager

Regulatory Professionals
United Kingdom
27 Sep 2017
03 Nov 2017
Contract Type
Full Time
Regulatory Manager Competitive salary Location: Hampshire Reference: J30655 Regulatory Professionals are working with a Pharmaceutical Development Organisation who provide a complete suite of drug development services to pharmaceutical and biotech clients around the world. They are seeking a Regulatory Manager with experience within the pharmaceutical, clinical research or biotechnology sector. Responsibilities include: * Acting as the lead regulatory professional on technical projects including preparing, reviewing and submitting regulatory submissions in compliance with the applicable SOPs, guidelines and legislation * Contributing to Clinical Trial Applications, Scientific Advice Procedures, Orphan Drug Designations, Paediatric Investigation Plans, ATIMPs, EU/Rest of World Marketing Authorisation Applications and Post Authorisation Submissions * Providing strategic regulatory and technical consultancy on projects, in a range of therapeutic areas Requirements: * Demonstrable experience in pharmaceutical/clinical project management from early stage to post marketing support in a client facing role * An in depth understanding of the regulatory landscape, especially within the UK, EU and US (and further) therefore allowing for the provision of strategic and quality advice * Extensive experience in delivering high quality deliverables on time, within budget and all whilst fulfilling clients' needs and maintaining engaged project teams regulatory affairs, manager, Pharmaceutical Development Organisation, PDO, SOPs, technical projects, UK, EU, US, client facing, Hampshire