ALTEN Portugal, 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
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.
* Regulatory Affairs Support:
* 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 Nordic or Arabic or Turkish Languages, written and spoken (Mandatory).
* Previous experience in Regulatory Affairs within the pharmaceutical industry, with a focus on artwork management and labelling (preferred)
* 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, Portugal.
Why Join Us?
* Possibility to work with cutting-edge technology in the Life Sciences industry
* Collaborative and dynamic work environment
* Possibility to join a top-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.