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The Company
Our client is a specialist in the manufacturer for the pharmaceutical sector. Due to growth, they are now looking to recruit a Regulatory Specialist.
The Role
- Manage and maintain EU, GB and EMEA authorisations of biocidal products; ensure compliance with other chemical regulations where applicable e.g. CLP; manage and maintain transitional biocidal registrations.
- Submission, maintenance, changes and renewals for products under EU BPR, GB BPR and other EMEA regulations as per market requirements.
- IUCLID dossier build, use of R4BP, preparation of SPCs, submission of IUCLID dossiers, preparation and submission of Poison Centre Notifications.
- Supporting Quality Assurance with implementing regulatory changes e.g. label artwork and Change Controls.
- Providing regulatory input for SDS preparation, marketing, sales, technical and R&D.
- Attend regulatory meetings in EU and elsewhere as required.
- Regulatory monitoring, including awareness of new regulations and changes to existing regulations, including internal communication of any potential impact to the company.
- Maintain compliance with other chemical regulations e.g., REACH, CLP, Detergents, as applicable for product range.
- Submission of annual biocidal product sales quantities to selected Member States.
- Liaise with all departments, project teams, suppliers, testing laboratories, distributors, consultants and Member State Competent Authorities to co-ordinate and monitor regulatory submissions and requirements
- Support other group sites with global disinfectant registrations.
- Could be full time or part time depending on the person.
- Could also offer remote working but site visits at least once a month or expected.
The Person
- Will have experience within a similar role.
- Must have biocides experience.
- You will have good IT Skills (Word, PowerPoint and Excel).
- Be proficient in use of IUCLID and R4BP.
- Good scientific communication (written and oral).
- Experience with human health toxicology and environmental risk and exposure assessments would be desirable.
- Experience with efficacy testing for regulatory purposes is desirable.
- Experience with CLP, REACH, SDS authoring and regulatory labelling would be beneficial.
The Benefits
- Discretionary annual bonus.
- Private Medical Insurance for you and your family.
- Pension Scheme.
- Corporate benefits platform and Cycle to Work Scheme.
- Death in Service Benefit.
- Remote or part time working.
