Providing regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities.
Liaising with Regional Submission Planner and Regulatory Operations.
Collaborating closely with country Regulatory Affairs staff in order to ensure timely submission to national Agencies.
Preparing the English Product Informationin collaboration with Worldwide Product Labelling.
For the centralized procedure, supervising and coordinating the local translation process to ensure timely submission to EMA.
Ensuring updates to regulatory databases.
Over jou
You have a degree in life sciences (biochemical, biomedical, pharmaceutical, ... sciences) and a first experience in the pharmaceutical industry.
Knowledge of EU regulatory procedures and development of medicinal products in general is preferred.
You are able to coordinate tasks with others for timely completion and to avoid setbacks
You demonstrates the ability to review regulatory documents for accuracy and understand the end-to-end pharmaceutical life cycle.
Wat wij bieden
We offer challenging projects and intensive, personal follow-up. We communicate transparently both before and after commencement of employment. You work in an informal human oriented environment where everything's negotiable. And last but not least there are plenty of inspiring network events and team buildings.