Your Role
You will be responsible for the regulatory management of a diverse pharmaceutical portfolio (OTC & Rx, generics, multiple dosage forms), covering national, MRP and DCP procedures (no centralized procedures).
Key responsibilities include:
* Defining and advising on regulatory strategy for new and existing products
* Managing regulatory submissions (new MAs, variations, renewals) in eCTD format
* Handling publishing activities and responses to Health Authorities
* Providing scientific and technical regulatory expertise, including Module 3 compliance
* Monitoring regulatory changes and advising stakeholders accordingly
* Acting as an RA expert within cross‑functional project teams
No people management is required in this position.
Your Profile
* Scientific Master's degree
* Solid experience in Regulatory Affairs (medior-senior level) within the pharmaceutical industry
* Strong knowledge of EU regulatory procedures (National, MRP, DCP)
* Autonomous, reliable, and comfortable in SME / family‑business environments
* Fluent in English and French; intermediate proficiency in Dutch
* Experience with medical devices, food supplements or cosmetics is a plus
What's Offered
* Full‑time position (5 days/week)
* No travel required
* Competitive salary package