REGULATORY AFFAIRS OFFICER (NORDIC/RUSSIAN/ARABIC SPEAKER)

ALTEN Spain, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and detail-oriented Regulatory Affairs Officer specialized in Artwork Management and Labelling with proficiency in Swedish, Finnish, Norwegian, Russian or Arabic.ALTEN GroupWithin 30 years, ALTEN has become leader in both outsourced Engineering and IT Enterprise Services. ALTEN, composed of 54,000 employees (88% engineers), carries out complex and highly technical projects throughout the value chain of 6,500 clients, the most prestigious companies in all sectors of industry, services and telecommunications. We work with key actors in the Aeronautics & Space, Defense & Naval, Security, Automotive, Rail, Energy, Life Sciences, Finance, Retail, Telecommunications and Services sectors.Do you want to work in exciting projects at renowned clients? At ALTEN we believe that knowing and meeting the expectations of our consultants is a key factor in our success. Our consultants make the difference. Do you want to make the difference too?As a Regulatory Affairs Officer, you will play a critical role in ensuring compliance with local and international regulatory standards across various markets.Responsibilities:Co-ordination of translation activities of English source text (e.g. EU Product Information (EUPI)) in cooperation with external vendor (central or local), ERMC team and LOCs.Ensuring the accuracy of the translated Product Information Annexes of Marketing Authorization against the reference English document in compliance with EU, reference country and /or local legislations.Performing and/or co-ordination of Quality Check (QC) of local PI– in cooperation with external vendor, LOCs and Medical Affairs as applicable.Maintaining the compliance of local PI and English translation in the Company validated repository system.Contribution to fast introduction of new products and line extensions including new indications.Use of Artwork management System to initiate artwork for new labelling or changes to current labelling into production and/or generation of mock-up needed for regulatory submissionsComplete review of the artwork (using electronic tool, where possible) and co-ordinate the final approval of the artwork with Local Operating Companies driven by the agreed deadlines.Entering data and using tools to monitor metrics for tracking of implementation of packaging materialLiaise with Local Operating Companies Regulatory Affairs, quality, Graphic Services, logistics/supply chain production plants internal/external to interpret current stock/orders to best anticipate ex-works date (available for delivery (AFD)) to meet both Health Authorities timelines and minimize current stock /component write off costs.Qualifications:Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field.Fluent in Swedish, Finnish or Norwegian (written and spoken) is a must.Previous experience in Regulatory Affairs within the pharmaceutical industry, with a focus on artwork management and labelling.Strong understanding of regulatory requirements for pharmaceutical products, particularly in Sweden, Finland or Norway and CIS countries.Attention to detail, with the ability to manage multiple tasks and projects simultaneously.Excellent communication and collaboration skills, with experience working in cross-functional teams.Familiarity with software and tools related to artwork and labelling management is a plus.Location: Full Remote, Spain.Why Join Us?Possibility to work with cutting-edge technology in the Life Sciences industryCollaborative and dynamic work environmentPossibility to join a top-leading company in the industryContinuous trainingsPossibility to join different and interesting projectsIf you want to embrace in a new and challenging opportunity and are excited about the opportunity to contribute to our team, we want to hear from you!