Excellence is part of us! Krka is one of the leading 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 to our team
REGULATORY ASSOCIATE
Search parameters:
* Education: B. Sc./M. Sc. in scientific field.
* Experience: entry level
* Languages: Proficiency in Dutch and English. Understanding of written French or German is desirable..
* The ability to produce high-quality product information (PI) texts.
* Strong linguistic skills and the ability to translate between English, French, German or Dutch.
* Ability to work effectively in a highly regulated field.
* Ability to put attention to detail also in routine work.
* The candidate should be able to prioritize and work effectively.
* Excellent PC use skills with regard to Word-processing, spreadsheets, database applications, and the internet. The work includes text editing.
After initial training the major working assignments would be:
* Your main task will be producing, maintaining, and editing PI texts.
* Supporting regulatory processes on the local level in close cooperation with Regulatory department. This includes the preparation of translations and ensuring their timely submission, regularly interacting with local authorities and Krka colleagues regarding product-related activities, and providing supplemental information for ongoing procedures.
* Verification and approval of artworks according to the last approved PI.
* Ensuring compliance with local regulatory requirements and Krka's policies and standard operating procedures in the fields of Regulatory Affairs, Good Distribution Practice, Pharmacovigilance, and Publicity and Information.
* Adequately supporting other functions to enable compliance in areas related to regulatory affairs.
* Be constantly updated on relevant EU and local regulations and guidelines.
* Handling GDP complaints and other quality tasks.
* Maintaining a positive relationship with internal and external regulatory contacts and other stakeholders.
Please send your CV with a motivational letter attached via LinkedIn. We are looking forward to your applications.