Regulatory Manager

Recruiter
Regulatory Professionals
Location
United Kingdom
Posted
28 Sep 2017
Closes
03 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
Regulatory Manager Hampshire, UK Salary: up to £80,000 per annum (experience dependant) plus competitive benefits package Job Reference: J30855 The company Regulatory Professionals are working with a well-established pharmaceutical consultancy who provide drug development services to pharmaceutical and biotech companies on a global scale. They are looking for a Regulatory Manager to join their collaborative senior team and act as the regulatory lead on multiple technical projects. Main responsibilities * Lead regulatory professionals on a number of technical projects * Prepare, review and submit regulatory submissions in compliance with the applicable SOPs and regulatory legislation * Contribute to Clinical Trial Applications, Scientific Advice Procedures, Orphan Drug Designations, Paediatric Investigation Plans and ATIMPs * Compile and submit EU/Rest of World Marketing Authorisation Applications and Post Authorisation Submissions (variations, renewals, etc.) The ideal candidate will possess the following skills: * A broad background within drug development with experience working with some or all of the following: Clinical Trial Applications, Scientific Advice Procedures, Orphan Drug Designations, Paediatric Investigation Plans, ATIMPs * Experience in EU/ Rest of World Market Authorisation Applications (MAAs) and Post Authorisation Submissions * Minimum of 5 years regulatory experience * In depth understanding of UK, EU and US markets - allowing for the provision of strategic advice Alternatively, if you know someone that may be interested in this role then please feel free to pass this advertisement on and if they are successfully place then you'll receive £250 worth of vouchers of your choice. MAA, CTA, PIPs, Drug development strategy, EU, RoW, Hampshire, Wiltshire, Berkshire, Sussex, Surrey, project management