Dossier Conformance Manager

SRG Clinical
01 Oct 2017
03 Nov 2017
Contract Type
Full Time
The Role:Perform conformance assessment between manufacturing documents and in-market dossiers filed with Europe and Emerging Markets Europe local Health Authorities, focusing on Module 3.Committed to quality and excellence in compliance and conformance. Key Responsibilities/Requirements: Data collection and evaluation in preparation for product and market assessment.Perform conformance analysis of source dossier with market dossierEnsure compliance systems accurately reflect market approval and manufacturing practicesOperate 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 understanding Good knowledge of content and requirements for CTD Module 3 Attention to detail.Demonstrated experience with a pharmaceutical company with proven examples of contribution.Knowledge and understanding of quality systems, processes, audit and inspectionExperience with maintaining electronic systems and databasesKnowledge on general standards, processes and policies of Pharmaceutical manufacturing Industry 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.