Excellence is part of us! Krka is one of the leading innovative generic pharmaceutical companies worldwide. We appreciate the knowledge and promote creativeness. We provide optimum working conditions. Creativity is our way of life and excellence is part of us.
KRKA Belgium would like to invite in our team REGULATORY ASSISTANT (on-site).
Responsibilities
* Your main tasks include producing, maintaining, and editing product information texts and packaging materials throughout the products' lifecycle.
* This includes the preparation of variations and new registrations of high quality to ensure timely submission.
* Verification of artworks for production according to the last approved product information.
* Adequately supporting other functions to enable compliance in areas related to regulatory affairs/quality/pharmacovigilance/healthcare compliance.
* Be constantly updated on relevant EU and local regulations and guidelines.
* You will be working on above tasks for Belgian, Dutch and French market, in cooperation with local teams.
Qualifications
* Education: Bachelor degree in Sciences (B. Sc.).
* Experience: entry level job
* Languages: Proficiency in Dutch and English. Basic French is desired.
Required Skills
* The ability to produce high-quality product information (PI) texts.
* Strong linguistic skills.
* Ability to work effectively in a highly regulated field.
* Ability to put attention to detail also in routine work.
* Good PC use skills with regard to Word-processing, spreadsheets, database applications, and the Internet.
* The work includes text editing.
* Good organizational and planning skills with the ability to focus on details.
* Good communication skills and proactive attitude.
We are looking forward to your application.