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Regulatory Specialist

MTrec Ltd Technical
Posted 18 days ago, valid for 4 days
Location

Ashington, Northumberland NE63 0AE, England

Salary

£48,000 - £55,000 per annum

Contract type

Full Time

Retirement Plan

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Sonic Summary

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  • The client is a manufacturer specializing in the pharmaceutical sector, currently seeking a Regulatory Specialist due to growth.
  • The role involves managing EU, GB, and EMEA authorizations of biocidal products, ensuring compliance with various chemical regulations, and maintaining transitional biocidal registrations.
  • Candidates should have experience in a similar role, specifically with biocides, and must be proficient in IUCLID and R4BP with good IT skills.
  • The position offers a salary of £40,000 to £50,000 and requires a minimum of 3 years of relevant experience.
  • Benefits include a discretionary annual bonus, private medical insurance, a pension scheme, and options for remote or part-time working.

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

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 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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By applying, a CV-Library account will be created for you. CV-Library's Terms & Conditions and Privacy Policy will apply.