Regulatory Affairs
Regulatory Affairs Officer
The RA Officer is responsible for initiating, submitting and following up registration dossiers of new products/line extensions as well as maintaining the existing product licenses according to the current legislation. He/she keeps product leaflets and packaging material updated according to the legal requirements. He/she is responsible for the Submission of Periodic Safety Update Reports to the Health Authorities in Belgium and the creation of price and reimbursement files.
Requirements
- Scientific degree
- Experience in and / or full understanding of pharmaceutical regulations
- Knowledge of Belgian and European legislation on medical products
- Ability to engage regulators in scientific discussions
- Excellent oral and written communication skills
- Detail-oriented
- Fluent in Dutch & English
- Teamplayer
- Pro-active, enthusiasm, keeping track of timelines
Regulatory Affairs Manager
The RA Manager is responsible for initiating, submitting and following up registration dossiers of new products/line extensions as well as maintaining the existing product licenses according to the current legislation. He/she keeps product leaflets and packaging material updated according to the legal requirements. He/she is responsible for the Submission of Periodic Safety Update Reports to the Health Authorities in Belgium and the creation of price and reimbursement files.
Requirements
- Scientific degree
- At least 5 years of experience in and / or full understanding of pharmaceutical regulations
- Knowledge of Belgian and European legislation on medical products
- Ability to engage regulators in scientific discussions
- Excellent oral and written communication skills
- Detail-oriented
- Fluent in Dutch & English
- Teamplayer
- People Management
- Pro-active, enthusiasm, keeping track of timelines
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