Regulatory Specialist

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