For one of our clients located in Brussels, we are looking for a RA Officer.
- Do you have a Master Degree in Pharmacy or in Life Sciences?
- Do you have 2 years of experience in Regulatory Affairs (Human Medicinal Products)
- Are you fluent in Dutch or in French and in English?
Then, you might be the candidate that we are looking for !
As RA officer, you have several responsibilities.
- You provide regulatory support in preparation of the submission and during the review of variations and all other regulatory activities in order to secure Agency submissions and approvals in compliance with applicable regulatory requirements.
- You complete and organize the gathering of the module 1 components.
- You collaborate closely with national Agencies in order to ensure timely approval by national Agencies.
- You ensure updates to regulatory databases.
- You keep up to date with EU procedural requirements and legislation.
- You have a MS degree in Pharmacy or in Life Sciences
- You have minimum 2 year's experience in Regulatory Affairs (human medicinal products).
- You have strong knowledge of EU and national regulatory procedures
- Knowledge about the development of medicinal products in general is an asset.
- You are fluent in Dutch or in French and in English
- You have good organizational skills and proven ability to multi-task.
- You demonstrate ability to coordinate tasks with others for timely completion and to avoid setbacks.
- You demonstrate the ability to review regulatory documents for accuracy.
- You understand the end-to-end pharmaceutical lifecycle
015 21 11 04