RA Manager H/F/X

Beschrijving van de functie

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. The role offers autonomy, stability, and long-term perspective in a pragmatic and agile environment.

A well-established, family-owned pharmaceutical company with a long history and a strong footprint in the BENELUX region. The organization operates in a stable SME environment, combining fast decision-making with high regulatory and quality standards.

The company specializes in the registration, lifecycle management, and commercialization of pharmaceutical products, including generics, OTC, and prescription medicines, across multiple dosage forms, within a highly regulated European framework.

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

Jouw profiel

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

Taalvaardigheden

• Frans (troef)

  • Begrijpen : Vaardig - (C1)
  • Schrijven : Vaardig - (C1)
  • Lezen : Vaardig - (C1)
  • Spreken : Vaardig - (C1)

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