About the role
The Regulatory Affairs Specialist is responsible for managing the lifecycle of the medicines from the preparation of the registration dossier, including the follow-up and finalization of new registrations, the preparation to market access, compilation, submission, and follow-up of variation dossiers in the Benelux.
Basically the RA specialist ensures quality delivery of regulatory activities for the BeNeLux market. Regulatory activities include but are not limited to:
- Submission of new MAA, life cycle management activities (submission and follow up for variations, renewals, MAH transfer and withdrawal), interaction with health authorities on behalf of customers.
- Compilation , or supervision of the compilation of regulatory dossiers in accordance with national requirements.
- Gain regulatory authority approval and manage follow up post-approval activities.
- Provide regulatory support to clients and associate companies.
- Liaise with regulatory authorities as required.
- Provide format and content review/approval of labelling documents (SmPC, PIL and packaging information).
- Degree in a scientific or (bio-)medical education (e.g. Pharmaceutical Sciences/Pharmacist, Bio-medical sciences, Drug Development, Lab technician or equivalent)
- Relevant work experience in a local BeNeLux Regulatory affairs role is a must have (minimum 1 year); this experience should include a proven understanding of the regulatory activities to be performed at local level for BeNeLux markets
- Good understanding of regulatory tracking database software, eDMS, MS Word, MS Excel
- You’re open-minded, collaborative, team player, ready to adapt to the changing needs
- You’re curious about new techniques and tools, and eager to always keep learning
- You have good organizational and planning skills
- You are detail oriented
- Knowledge of pharmaceutical terminology is a plus
- You are fluent in Dutch, French and English
What is the offer?
Ability to join a young and dynamic company where people count and make the difference.
Opportunity to grow your current skills set in different domains including regulatory and medical affairs, pharmacovigilance and market access.
A huge amount of flexibility in terms of hybrid working.
Want to take this challenge?