Regulatory Affairs Specialist – Biocides (EU/GB BPR)
The Regulatory Affairs Specialist will support and deliver regulatory activities for biocidal products, with a primary focus on the EU and GB Biocidal Products Regulation (BPR). The role will contribute directly to ongoing regulatory projects, including national authorisations under the transitional period, dossier maintenance and development, and regulatory support for both EU and non‑EU markets.
This is a hands-on regulatory role, suited to someone with existing BPR experience who is comfortable working with dossiers, data requirements, and competent authorities, and who can manage defined regulatory workstreams with increasing independence.
Key Responsibilities
Biocides Regulatory Activities (EU & GB)
- Support and manage national product registrations under the BPR transitional period.
- Compile, update and maintain biocidal product dossiers, including IUCLID and supporting documentation.
- Conduct data gap analyses against current regulatory requirements and authority feedback.
- Support study planning, contracting, and monitoring, including liaising with CROs and laboratories.
- Track regulatory timelines, deliverables and authority requests.
Authority & Stakeholder Liaison
- Liaise with Competent Authorities, consultants and service providers on regulatory submissions and follow‑up questions.
- Support responses to authority requests for information (RFI), including technical and regulatory clarifications.
- Work closely with internal stakeholders (Quality, Technical, Sales, Operations) to gather and interpret required data.
Internal & Customer Regulatory Support
- Respond to internal colleague queries relating to BPR requirements, product classifications and regulatory status.
- Support responses to customer regulatory questions, in collaboration with senior regulatory staff.
- Contribute to clear, accurate regulatory messaging on products and markets.
Non‑EU and Global Support
- Support non‑EU regulatory registrations, working with local representatives and consultants as required.
- Assist in compiling regulatory documentation and tracking country‑specific requirements outside the EU/GB.
Required Experience & Qualifications
- 2–5 years’ experience working in Regulatory Affairs with biocidal products under the EU BPR and/or GB BPR.
- Practical experience with:
- National registrations under the BPR transitional period
- Dossier compilation and maintenance
- Data gap analysis and study coordination
- Regulatory correspondence with authorities or consultants
- Degree in a scientific discipline (e.g. chemistry, biology, toxicology, life sciences or similar).
- Good working knowledge of:
- Regulation (EU) No 528/2012 (BPR)
- Article 95 requirements
Desirable Experience
- Experience with disinfectant products (e.g. surface, hand or instrument disinfectants).
- Understanding of REACH and CLP regulatory frameworks
- Exposure to non‑EU regulatory frameworks.
- Experience working in a manufacturing or commercial environment.
Skills & Competencies
- Strong attention to detail and ability to manage regulatory documentation accurately.
- Ability to prioritise and manage multiple regulatory tasks in parallel.
- Confident communicator, able to liaise with authorities, consultants and internal colleagues.
- Comfortable working with ambiguity and evolving regulatory requirements.
- Pragmatic, solution‑focused approach with a willingness to ask questions and escalate appropriately.
Pay: £40,000.00-£55,000.00 per year
Work Location: Hybrid remote in Stockton-On-Tees TS21
