Life Sciences | Regulatory Affairs Officer - Multiple Speakers Viseu

Life Sciences | Regulatory Affairs Officer - Multiple Speakers
Viseu
Viseu, Viseu District, Portugal

ALTEN Portugal , a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and
- oriented Regulatory Affairs Officer specialized in Artwork Management and Labelling. ALTEN Group
Within 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. Key Responsibilities:Artwork Management:Review and approve artwork to ensure compliance with regulatory standards and requirements. Coordinate with internal and external stakeholders, including design, marketing, and packaging teams, to ensure artwork is accurate and meets regulatory guidelines. Ensure timely updates of artwork to reflect any regulatory changes, including packaging and labelling components. Labelling Compliance:Prepare, review, and update product labels in compliance with
- specific regulations, particularly in Russian-speaking markets. Translate and localize product labels and packaging content into Russian, ensuring accuracy and compliance with local regulatory requirements. Collaborate with
- functional teams to ensure labelling updates are implemented effectively and on time. Regulatory Affairs Support:Monitor regulatory changes and updates in Russia and other relevant markets, ensuring the company is compliant with local and international regulatory frameworks. Assist in the submission of regulatory dossiers, amendments, variations, and renewals for marketing authorizations. Liaise with health authorities and regulatory bodies, providing timely responses to regulatory queries and requests. Qualifications:Bachelor’s degree in Life Sciences, Pharmacy, Regulatory Affairs, or a related field. Fluent in Turkish, Arabic/Hebrew, French, German, or Swedish (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 Russia 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
- functional teams. Familiarity with software and tools related to artwork and labelling management is a plus. Location: Full Remote, Portugal. Why Join Us? Possibility to work with
- edge technology in the Life Sciences industry
Collaborative and dynamic work environment
Possibility to join a
- leading company in the industry
Continuous trainings
Possibility to join different and interesting projects
If 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! Please submit your resume and cover letter detailing your relevant experience and qualifications.