My Client a Global Pharmaceutical Company has opened a new vacancy within their Regulatory team. They are looking to recruit a Regulatory CMC Consultant on a 12 Month contract basis to their offices in the North West.The Role:My client has a position available for an individual who shares our passion to join the Regulatory Documentation team, Documentation for the CMC part of submissions is one of the key project deliverables from Pharmaceutical Development. The CMC Regulatory Documentation supports clinical trials and marketing applications to obtain our commercial manufacturing license. As a CMC Documentation Lead you will be a key member of the project team and have an opportunity to develop a deeper understanding of the regulatory processes.Key Responsible: * Accountable within Pharmaceutical Development for the production and delivery of CMC sections of all regulatory documents e.g. marketing and clinical study applications, responses to Health Authority questions and briefing documents. The major tasks include* Define which CMC documents are required * Prepare for and run the CMC Submission Kick Off meeting* Lead the delivery team (authors, reviewers, approvers) for the CMC part of submissions* Lead the review process for all CMC documents, consolidating all comments* Drive the completion and on-time approval of all CMC documents to submission ready standardsMinimum Requirements -Education and Experience:* A University degree preferably Chemistry or Pharmacy * Proven experience working in a science area with the drug development process involving regulatory documentation using Document Management Systems, e.g., ANGEL* Demonstrated strong interpersonal, motivational and leadership skills * Excellent written and verbal in English * Evidence of acting decisively, collaborative working, strategic leadership, commitment to customers and integrity, driving accountabilities with people at all levels and within drug product delivery teams.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 589626
The 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.