We are recruiting a Regulatory Affairs Manager to join a well‑established, family‑owned pharmaceutical SME with a strong presence in the BELUX and NL markets. * Solid experience in Regulatory Affairs (medior-senior level) within the pharmaceutical industry - The organization operates in a stable SME environment, combining fast decision‑making with high regulatory and quality standards. 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). * Defining and advising on regulatory strategy for new and existing products * Managing regulatory submissions (new MAs, variations, renewals) in eCTD format * Providing scientific and technical regulatory expertise, including Module 3 compliance * Monitoring regulatory changes and advising accordingly
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