Regulatory Affairs Officer

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  • Hybrid
  • Permanent
  • Pharma/biotech
  • Regulatory Affairs Officer

Novellas Healthcare is looking for a driven Regulatory Affairs Officer for a challenging and varied position within a family-owned pharmaceutical environment in Walloon Brabant.

Vacancy information

You will join an experienced RA & QA team and take on a broad range of responsibilities within Regulatory Affairs. At the same time, you will have the opportunity to further develop your expertise towards Quality Assurance. This is a great opportunity for an experienced RA professional who enjoys a hands-on approach, variety and responsibility.

Your responsibilities:

  • You manage regulatory activities related to medicinal products and product information, including artworks, mock-ups, labelling, PILs and SmPCs.
  • You coordinate variations, notifications and lifecycle management.
  • You prepare regulatory dossiers and relevant sections, working closely with internal and external partners.
  • You coordinate proofreading and ensure that product information and packaging materials comply with applicable requirements and QRD guidelines.
  • You closely monitor developments in Belgian and European regulations.
  • You collaborate with, among others, Marketing and Supply and provide support with QA-related activities when required.
  • Knowledge of food supplement legislation is a strong asset. Experience with QA/GMP or cosmetics is a plus, but not a requirement.

Requirements information

  • You have at least 5 years of experience within the pharmaceutical industry, including relevant experience in Regulatory Affairs.
  • You have a solid knowledge of medicinal products, regulatory legislation and guidelines.
  • You are hands-on, accurate and autonomous, while also enjoying working as part of a team.
  • You like taking responsibility and are keen to further develop your expertise within a broad RA role.
  • French and English are important. Dutch is a plus. Dutch-speaking candidates with a good command of French or English are also welcome.
  • You are willing to work at least 3 days per week on site.

What do we offer

  • A permanent, full-time position within a family-owned pharmaceutical company.
  • A broad and varied RA role with room to further develop your expertise towards QA.
  • 20 statutory + 10 additional days of leave.
  • €10 meal vouchers per working day.
  • Group insurance.
  • Hospitalization insurance.
  • Possibility to work from home up to 2 days per week.
  • Commuting allowance.

Ready for your next step in Regulatory Affairs?

We would be delighted to hear from you.

Novellas Healthcare is an equal opportunity employer. We welcome every talent and do not discriminate based on gender, ethnicity, religion, disability, sexual orientation or any other personal characteristic.

Regular application

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Myriam Van Londersele

Vacancy ID: V-0877

Sr. Staffing Manager

3224560000

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