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Regulatory Specialist

Ashington
5 months ago
Applications closed

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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 and BPR 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

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