Regulatory Affairs Consultant

Recruiter
SRG Clinical
Location
Hertfordshire
Posted
01 Oct 2017
Closes
03 Nov 2017
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
The Role: * Planning, preparation and submission of MA applications, variations, renewal documents, post marketing commitment submissions and other activities in maintaining MAs in MENA, Africa, UK and possibly other RoW territories. * Reviewing and submitting artwork and labelling changes. * Building and maintaining effective relationships with external clients/partner’s alongside partner’s regulatory teams. * Managing/supporting a range of changing project demands. * Gap analysis of regulatory documentation, identification of potential challenges and proposal of solutions. * Liaising with regulatory authorities for advice and guidance when necessary, and to resolve issues to achieve the best possible outcome for the business. * Ensuring all processes are carried out according to guidelines and standard operating procedures (SOPs).Requirements: * Bachelor’s degree equivalent or higher education within Pharmaceutical or relevant life science. * Regulatory affairs experience and knowledge of MHRA, EMA and MENA regulations. * Ability to multitask and manage multiple decisions and also capacity to react quickly and decisively in unexpected situations. If you are interested in this role or would like to have a confidential career discussion regarding other Regulatory Opportunities. Please contact me: or +441753 589673The recruiter has stated that all applicants for this job should be able to prove they are legally entitled to work in the EU/UK. SRG is a trading name of Science Recruitment Group Ltd an Employment Business/Agency.