Regulatory Affairs Officer
- Contract
- Pharmaceutical
For an international player within the pharmaceutical industry (RX & OTC), we are looking for a Regulatory Affairs Officer.
Vacancy information
A Regulatory Affairs Officer in a pharmaceutical company plays a critical role in ensuring that the company follows all the regulations and laws. In essence, the Regulatory Affairs Officer acts as a bridge between the pharmaceutical company and regulatory authorities, ensuring that all products meet the required legal and regulatory standards while supporting the company’s business objectives.
In this role you will report to the Head of Regulatory Affairs Western Europe.
Main responsibilities:
· Accurate and prompt submission of registration dossiers for RX and OTC drugs in Belgium.
· Follow-up and maintenance of existing registrations.
· Update changes to registrations and follow up on legislation and regulations in Belgium and Luxembourg.
· Review and submission of promotional material.
· Tracking innovations (potential launches), assessing regulatory strategies and timelines.
· Occasional backup for regulatory team colleagues.
Requirements information
· First experience in Regulatory Affairs (experience in Consumer Health is a plus).
· You have knowledge of basic RA activities such as: type variations, registrations, procedures, inserts/formats.
· Fluent in English / Dutch / French – written & spoken
· You are expected to take responsibility for yourself.
· Attending meetings where you dare to ask questions and be able to provide an enriching debrief to your supervisor and your team.
· Daring to get out of your comfort zone to learn new things and to share your own ideas.
· If you miss certain info you take the initiative to look it up.
· Not an ‘executive’ attitude but a ‘thinking along’ attitude.
· Pro-active attitude is crucial.
· Ability to tackle your tasks in a structural way.
· Strong administrative skills.
· Be able to set your own priorities in your work to deliver on time.
· Good knowledge of MS office.
