Regulatory Affairs Officer – EU
Marketing authorisation holder, Amsterdam
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- Amsterdam, NL · Hybrid
- Permanent
- €58–70k per year
- Start: Flexible
- Ref. BL-1047
Posted
About the role
An MAH with a European generics and specialty portfolio is adding an RA Officer to its Amsterdam lifecycle team. You own around thirty products registered via DCP and MRP with the Netherlands frequently acting as RMS, and you are the RA interface for QA change controls at two contract manufacturers.
Your responsibilities
- Prepare and submit variations (IA/IB/II), renewals and PSUR-related updates
- Assess change controls from CMOs for regulatory impact
- Maintain product information and artwork approvals
- Coordinate with the CBG-MEB as RMS and with EU affiliates
- Keep the RIM system and eCTD sequences current
What you bring
Must-haves
- MSc in pharmacy, pharmaceutical or biomedical sciences
- 2–5 years EU regulatory affairs with own variation portfolio
- DCP / MRP procedure experience
- Fluent English
Nice-to-haves
- CMC / Module 3 experience
- Dutch (for CBG-MEB national correspondence)
- Veeva Vault RIM
What's offered
- €58,000–70,000 gross per year plus 8 % holiday allowance
- Hybrid: 2 days on site, laptop and home office budget
- Pension, 27 days leave, TOPRA training budget
- Path to Senior RA / CMC specialist
About the company
A European MAH with around 80 staff in the Netherlands and a portfolio of 200+ marketing authorisations.
How we screen this role
The founder discusses one variation you owned end to end, classification, assessor questions, outcome, and one change control you assessed.
Apply for this role
Regulatory Affairs Officer – EU · BL-1047
Regulatory Affairs Officer – EU
€58–70k