RA Manager

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

To find out more about Real please visit www.realstaffing.com