Healthcare Scientist

Job Title:Regulatory Life Cycle Management Scientist (Personal Health Care) 31ph PAYE (depends on experience) Employment Type: Contract (12 months) The GPS Global Regulatory Affairs Life Cycle Management Team has a 1-year position available to build Medicinal Product capability in and outside Europe. Our Client is looking to hire a candidate strongly interested in Regulatory Affairs having experience in medicinal products. The candidate will act as the point of contact for our local regulatory colleagues, who manage local market and authority interactions, as well as with other technical and non-technical functions like MPD, Product Supply, QA, Marketing and manufacturing sites. Build medicinal capability within Regulatory Affairs Life Cycle Management and ensure medicinal aspects are well reflected in projects, work processes, and in our systems. Enable PHC business for the relevant portfolio within and outside Europe region by delivering to time and to GPS SOPs on agreed and aligned priority base business projects across each franchise & region, as well as on “LCM initiatives” requiring changes to existing products/dossiers. Co-ordinate Regulatory Life Cycle Management activities across multiple countries within and outside Europe. Co-ordinate with Local Regulatory Affairs for variations, renewals and answering health authority requests. Maintain Global Master Dossiers and compile, review, and provide dossiers for local registration and compliance to achieve variations for the specific product portfolio. Advise organization of potential regulatory risks in normal day-to-day activities and recommend compliant actions. Ensure regulatory assessments are conducted for change controls in the respective Veeva Quality Tracking System. Ensure that the Veeva Regulatory Information Management System is maintained and updated for all activities under role responsibility, including review of documents. Provide strategic input into Regional Product labelling and approval to enable commercial activation of product launches. Contribute to new regulatory policies, systems and processes to reinforce governance and compliance across LCM and the regulatory Affairs function. A minimum of a Masters’ degree in pharmacy, engineering, chemistry with knowledge in Regulatory Affairs. Languages: Proficiency in English. Geography: Professional with initial strong regulatory affairs experience, preferably in consumer health and preferably across multiple regulatory classification areas. Strong motivation for dossier maintenance and product change management. Skilled in working with complex Regulatory Databases. Strong initiative and follow-through with accountability for work quality. We are an independent highly-experienced recruitment consultancy dedicated to specialist markets within the Automotive, Aerospace, Agricultural & Construction Industries. No terminology within this advert is intended to unlawfully discriminate on the grounds of age, sex, race or disability and we welcome all applications. #