ALTEN Portugal, a leading force in the IT, Engineering and Life Sciences industries. We are currently seeking a dedicated and detail-oriented Regulatory Affairs Technician to join our dynamic team in the Life Sciences division.
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 crucial role in the preparation and review of regulatory documentation, ensuring that all materials submitted by clients comply with applicable requirements.
Key Responsibilities:
* Managing and maintaining AIMS (including reviewing and modifying regulatory data).
* Drafting, updating and submitting regulatory texts, including eCTDs.
* Managing a portfolio of products, ensuring compliance with regulatory deadlines.
* Support in preparing and submitting variations, renewals and other regulatory procedures.
Qualifications:
* Education: Bachelor's degree in Pharmacy, Life Sciences, or a related field.
* Experience: Minimum of 2 years of experience in regulatory affairs within the pharmaceutical or life sciences industry.
* Knowledge: Knowledge of regulatory processes, including variations, renewals and compliance with INFARMED guidelines and other authorities. It is essential to be familiar with AIMS and technical requirements to ensure compliance and efficient portfolio management.
* Languages: Knowledge of English is mandatory
Location: Hybrid, Vale de Cambra.
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.