Overview
We are seeking an experienced EU Biocide Registration Consultant to oversee the management and submission of national marketing authorization applications for swimming pool disinfectant products across five EU member states. The consultant will closely collaborate with our team to ensure adherence to regulatory requirements and streamline the approval process for our chlorine product range. This fully remote role will play a critical part in expanding our European operations.
Responsibilities
- Review existing documentation and produce a written data gap analysis per product per country.
- Produce a strategy report covering requirements, authority fees, and realistic timelines for each country.
- Define and manage the efficacy testing programme, including laboratory selection and study monitoring.
- Prepare complete application dossiers compliant with each national authority's requirements.
- Submit applications and manage all correspondence with authorities through to final decision.
- Coordinate with our manufacturer to obtain formulation data, certificates of analysis, and raw material safety data sheets.
- Provide written progress updates at least fortnightly and flag risks early.
- Hand over complete records, submission references and authorisation certificates on completion.
Requirements
- Demonstrated experience preparing and submitting biocidal product applications under Regulation (EU) No 528/2012 in at least two of the five target countries.
- Working knowledge of national transitional procedures under Article 89 BPR.
- Familiarity with PT2 disinfectants and the associated efficacy testing requirements, for example EN 1276, EN 1650, and EN 13623.
- Experience preparing PCN dossiers in IUCLID and submitting through the ECHA portal.
- Ability to prepare or coordinate multilingual label and SDS requirements.
- Available to start within four weeks.