Regulatory Compliance Coordinator

SRG Clinical
03 Oct 2017
02 Nov 2017
Contract Type
Full Time
The Role:Reporting to the Europe Regional Lead, working in close collaboration across the regulatory organization between Global, Regional and Country teams to support Post Approval Regulatory Submissions. Key Responsibilities/Requirements: Support Post Approval CMC submissions for MRP/DCP/CP Licenses, ensure compliance systems fully reflect health authority statusMaintain systems and databases per internal SOPs and policiesOperate to the highest conformance standardsOperate in line with internal SOPs and policiesLiaise with regulatory colleagues to communicate and resolve potential issues Skills/Experience Required: Bachelor’s degree or equivalent i.e. degree in Chemistry, Pharmacy, or a related life sciences.Experience in a Regulatory or compliance role within the pharmaceutical industry –Strong compliance focus and understandingGood knowledge of content and requirements for CTD Module 3Knowledge and understanding of quality systems, processes, audit and inspectionMaintain systems and databases per internal SOPs and policies 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 589626The 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.