Regulatory CMC Associate Location: MacclesfieldContract duration: 12 monthsRemuneration: Competitive hourly rateRegulatory CMC Associate are required to produce and support the production of Chemistry, Manufacturing and Control (CMC) documentation for designated commercial products at various stages of product life cycle, in the required format and to the agreed timetable.The Regulatory CMC Associate is responsible for:Providing CMC regulatory and compliance advice on regulatory post-approval submissionsWorking cooperatively with stakeholders across CMC Regulatory Compliance, Global Regulatory Affairs and OperationsSupporting the timely submission of post approval CMC documentationCoordinating assembly and/or generate documentation of submission-ready components to support life cycle submissionsReview and approval of regulatory CMC documents on behalf of CMC Regulatory ComplianceSupport cross-functional approval for delivery of the documentation to Global Regulatory Affairs for worldwide use in regulatory submissionsNotify manufacturing sites of health authority approvalsUpdating all relevant electronic systems to be consistent with regulatory submissions and commitments.Skills Required:Graduate in a scientific discipline eg chemistry, pharmacy or biological scienceBasic knowledge of the drug development process and regulatory submissionsExperience in Pharmaceutical Production, Regulatory Affairs, Quality Assurance, R&DUnderstanding of current regulatory CMC requirements This position would be suitable for a recent graduateHays Talent Solutions is a trading division of Hays Specialist Recruitment Limited and acts as an employment agency for permanent recruitment and employment business for the supply of temporary workers. By applying for this job you accept the T&C's, Privacy Policy and Disclaimers which can be found on our website.