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Senior Regulatory Affairs Specialist – Biocides & Expansion Markets

Life Sciences
Regulatory Affairs
Bachelor, Master
Advanced (5+)
Emplacement
Limbourg
Type de travail
Permanent
Modèle de travail
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.

Responsabilités

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. As the organization launches a dedicated regulatory-affairs-as-a-service branch, you'll join a small, ambitious team where in-house regulatory expertise is the core of what they do — with real ownership as the company grows its client base and Southern European presence.

Responsibilities

Working closely with the head of the department, you'll take full ownership of complex BPR registration dossiers, bridging technical data and market access. You'll advise both internal stakeholders and clients on regulatory strategy and market access.

  • Taking full ownership of EU BPR dossiers for active substances and product authorisations, with a focus on insecticides (PT18) and repellents (PT19), alongside PT14
  • Independently compiling and submitting IUCLID dossiers via R4BP 3, including Technical Equivalence and Article 95 matters
  • Coordinating complex physicochemical, stability, toxicological, and study packages with external labs and toxicologists — and critically assessing their input rather than simply relaying it
  • Performing gap analyses between existing data/studies and dossier requirements for new submissions
  • Maintaining and actively building professional relationships with competent authorities (eCA), ECHA, and national bodies — confidently negotiating and defending regulatory positions
  • 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, including market-access assessments for suppliers seeking entry to the EU market
  • Contributing to the build-out of the regulatory-consultancy offering itself — shaping how the service is positioned and delivered as it scales

Exigences

  • A Master's or PhD in Chemistry, Toxicology, Life Sciences, or a comparable discipline
  • Around 10 years of relevant regulatory affairs experience, with hands-on, independent ownership of EU BPR dossiers — you've built and defended a dossier yourself, not just supported one
  • Deep, working knowledge of IUCLID and R4BP 3
  • Solid grasp of physicochemical, stability, and multi-study data packages, including hazard & risk and toxicology
  • An established network with authorities, laboratories, or toxicologists is a strong asset — it opens doors and speeds up processes
  • Comfortable operating at both strategic and operational level, and confident challenging external partners on their scientific and technical input
  • Entrepreneurial mindset: genuine motivation to help build out a new consultancy offering, not just execute within an existing one
  • Fluency in English and a good active command of Dutch

Offre

  • Permanent contract of indefinite duration
  • Competitive, market-conform salary reflecting seniority and impact, adjusted to your location
  • Company car, meal vouchers, group insurance, and hospitalisation insurance
  • Flexible base location across Europe, with regular presence expected at the team's office, particularly during the initial onboarding period
  • A flat, accessible team structure with short communication lines
  • 20 statutory holidays + 5 ADV days + 1 additional day
# 100575
Avec un signe plus et l'indicatif du pays (par exemple +32 400 00 00 00).
Nous acceptons les fichiers Word et PDF jusqu'à 3 Mo.
Les candidats doivent être légalement autorisés à travailler dans l'UE et posséder les compétences linguistiques requises pour le lieu de travail.
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Zoë Schelftout

Zoë Schelftout

Téléphone
+32460257396