Regulatory Affairs Specialist

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My client is seeking a Regulatory Affairs Specialist to join their busy team based in Cork. This role has opened up due to growth in business so they are seeking an experienced specialist who is looking for the next step in there career.Reporting to the Regulatory Affairs Manager you will have responsibility for monitoring regulatory compliance across multiple territories. This company are leaders in the supply high-quality generic medicines.The key function of this role is to ensure a high level of regulatory compliance, supporting regulatory submissions, ensuring product safety and labelling compliance.You will monitor multiple global suppliers to ensure regulatory compliance, generate metrics and prepare reports for the regulatory department.Key ResponsibilitiesPerform Regulatory Affairs activities ensuring compliance with applicable regulations and requirements (FDA, HC, MHRA, HPRA)Oversee and contribute to the preparation of regulatory submissions and registrationsPrepare, review and/or approval of regulatory change controls, risk assessmentsRespond to Competent Authorities' queries and deficiencies in a timely mannerReview and approval of artwork for UK market, including colour selection and approval of digital proofs.Monitor RLD revisions and maintain up to date current and historical recordsOversee product registration and delisting as appropriate (SPL, CMS)Experience:5+ years FDA regulated pharmaceutical experience; 2-3+ years regulatory affairs experience Degree educated in a scientific disciplineThorough understanding of regulatory and compliance guidelines within pharmaceutical manufacturingFamiliarity with concepts of Regulatory Approval process for generic pharmaceutical products an advantage To find out more about Real please visit www.realstaffing.comReal Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales