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Regulatory Affairs Specialist – Biocides & Expansion Markets

Life Sciences
Regulatory Affairs
Bachelor, Master
Advanced (5+)
Locatie
Limburg
Type werk
Permanent
Werkmodel
Fulltime, On-site

Our client is a specialized knowledge partner based in the province of Limburg, guiding international suppliers through the registration of biocidal products on the EU market. You'll be joining a small, ambitious team where in-house regulatory expertise is the core of what they do and where there's real room to take ownership as the organization grows into adjacent regulatory frameworks and international markets.

Verantwoordelijkheden

Working closely with the head of the department, you'll be the driving force behind complex registration dossiers, bridging technical data and market access. You'll advise both internal stakeholders and clients on regulatory strategy and market expansion.

  • Managing and following up on EU BPR dossiers for active substances and product authorisations (PT14, PT18, PT19)
  • Coordinating complex physicochemical, stability, and study packages
  • Independently compiling and submitting IUCLID dossiers via R4BP 3
  • Maintaining professional contacts with competent authorities (eCA), ECHA, and national bodies
  • Supporting the expansion into adjacent frameworks such as plant protection products (EU 1107/2009) and veterinary applications
  • Analysing data gaps and study requirements across different international regulatory frameworks
  • Contributing to regulatory strategy for export markets in the US, Latin America, and Africa
  • Drafting Letters of Access, Letters of Supply, and related technical documentation
  • Acting as the technical point of contact for business development on complex regulatory questions from clients

Vereisten

  • A Master's or PhD in Chemistry, Toxicology, Life Sciences, or a comparable discipline
  • 4 to 8+ years of relevant experience in regulatory affairs with a strong focus on EU BPR legislation
  • Hands-on experience with IUCLID and R4BP 3
  • In-depth knowledge of physicochemical, stability, and multi-study data packages
  • Strong analytical skills, attention to detail, and a solid sense of responsibility
  • Confident communication skills and the ability to lead projects independently
  • Fluency in English and a good active command of Dutch
  • Affinity with plant protection or veterinary regulatory frameworks is a strong asset
  • Willingness to develop expertise in international registration systems outside the EU

Aanbod

  • Permanent contract of indefinite duration
  • Company car, meal vouchers, group insurance, and hospitalisation insurance
  • Full-time position based in the province of Limburg
  • Hybrid working model: 2 days from home after a 6-month onboarding period
  • A flat, accessible team structure with short communication lines
  • 20 statutory holidays + 5 ADV days + 1 additional day
# 100575
Met een plusteken en landcode (bijv. +32 400 00 00 00).
We accepteren Word- en PDF-bestanden tot 3 MB.
Kandidaten moeten wettelijk gerechtigd zijn om in de EU te werken en over de vereiste taalvaardigheden voor de joblocatie beschikken.
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