Regulatory Affairs Assistant
A fantastic opportunity has become available for a reliable Quality and Regulatory Affairs Assistant to join our Quality and Regulatory Affairs department in the execution of regulatory activities.
Assisting the Quality and Regulatory Affairs Manager on the daily tasks.
Preparing quality documentation and reports by collecting, analysing and summarising information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
Developing and writing clear arguments and explanations for new product licences and licence renewals;
Preparing regulatory submissions and renewals
Writing clear, accessible product labels and patient information leaflets;
Providing strategic and operational regulatory support in preparation of the submission and during the review of new Marketing Authorisation Applications, variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
Collaborating closely with the Regulatory Affairs Specialist in order to ensure timely submission to national Agencies.
Preparing the Product Information (Summary of Product Characteristics, label and leaflet)
Ensuring updates to regulatory databases.
Keep up to date with regulatory requirements and legislation.
A university, bachelor’s degree or equivalent in life science,
Ability to take on diverse tasks, good organisational skills.
Outstanding communication skills
Great attention to detail and a results driven approach
Excellent organisational and leadership abilities
Integrity and a professional approach to work
Strong appreciation of both legal and scientific matters
The ability to work under pressure and to strict deadlines
Fluent in English, and French.
Permission to work in Belgium.