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
1. 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.
2. Submission, maintenance, changes and renewals for products under EU BPR, GB BPR and other EMEA regulations as per market requirements.
3. IUCLID dossier build, use of R4BP, preparation of SPCs, submission of IUCLID dossiers, preparation and submission of Poison Centre Notifications.
4. Supporting Quality Assurance with implementing regulatory changes e.g. label artwork and Change Controls.
5. Providing regulatory input for SDS preparation, marketing, sales, technical and R&D.
6. Attend regulatory meetings in EU and elsewhere as required.
7. Regulatory monitoring, including awareness of new regulations and changes to existing regulations, including internal communication of any potential impact to the company.
8. Maintain compliance with other chemical regulations e.g., REACH, CLP, Detergents, as applicable for product range.
9. Submission of annual biocidal product sales quantities to selected Member States.
10. 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.
The Person
1. Will have experience within a similar role.
2. Must have biocides experience.
3. You will have good IT Skills (Word, PowerPoint and Excel).
4. Be proficient in use of IUCLID and R4BP.
5. Good scientific communication (written and oral).
6. Experience with efficacy testing for regulatory purposes is desirable.
7. Experience with CLP, REACH, SDS authoring and regulatory labelling would be beneficial.
The Benefits
1. Discretionary annual bonus.
2. Private Medical Insurance for you and your family.
3. Pension Scheme.
4. Corporate benefits platform and Cycle to Work Scheme.
5. Death in Service Benefit.
6. Remote or part time working.
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