Regulatory Affairs Specialist

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My client, a pharmaceutical company based in North Dublin, are looking for a Regulatory Affairs Specialist to join their expanding team. Responsibilities;The Regulatory Affairs Specialist undertakes responsibility for a number of key tasks in our submission team which ranges from submission of MAAs (generic/bibliographical) in the EU via national, MRP and DCP routes, and managing post-licensing activities (variations, renewals, Sunset Clause, etc.). The Regulatory Affairs Specialist manages assigned RA tasks in line with current EU requirements, relevant internal procedures and in line with partners' expectations. Additionally, the Regulatory Affairs Specialist will provide regulatory support for out-licensing activities in EU and non-EU territories. The Regulatory Affairs Specialist actively contributes to development of the Regulatory Department, maintains and improves the regulatory systems and procedures and works cross-functionally and in collaboration with different Departments both internal (eg, R&D, Licensing, Quality, etc) and external (eg, Competent Authorities, Clients, Suppliers, etc) Education and Experience;The successful candidate has a strong educational background in a relevant Life Science Degree or MSc and has at least 6 years of experience in Regulatory Affairs for pharmaceutical generic industry. Solid experience with Module 3 documentation is desired. Proven experience working in a fast-paced dynamic team is considered an advantage Excellent benefits and salary on offer with this role. 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