Regulatory Affairs Specialist
Have you completed your studies and are you looking for a new challenge? In this role you will be trained to become a Regulatory Affairs Specialist for a pharmaceutical company.
Omschrijving
Regulatory Affairs is responsible for ensuring product safety, quality, and compliance with the laws and regulations of the country where the product is sold. Each country has its own rules, such as paracetamol being packaged in a white box in the Netherlands and ibuprofen in a red box. RA ensures that a product is registered and approved in the respective country so that it can be used in that country.
Location: Eindhoven
Hours: Full-time
Wat ga je doen?
In this role, you will be trained to become a Regulatory Affairs Specialist. You will be involved in tasks ranging from drafting registration dossiers to acting as a contact person for stakeholders around the world. Your responsibilities will expand until you can handle processes from A to Z. You will be guided by two RA professionals who will teach you all there is to know about RA. Additionally, you will report to the RA Manager.
Your responsibilities include the following
- Preparing and reviewing product documentation
- Registering new and existing medicines
- Drafting registration Dossiers
- Acting as the contact person for internal and external stakeholders
- Staying informed about developments and trends in RA
Jouw profiel
- Relevant MSc or BSc degree (Chemistry or Biology)
- Relevant work experience in the field of RA is a plus
- Good communication, reading and writing skills in English
- You are a proactive person and show ownership
- You enjoy working within an international team/organisation
