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Regulatory Affairs Manager

Food and FMCG

Leicestershire
(£) Competitive
permanent
Job Ref: 6989

Description

A manufacturer of food supplements and medicinal products has an exciting opportunity for a Regulatory Affairs Manager to join its team. Your role will be to manage the Regulatory Department  to ensure that the company meets all regulatory and QA guidance / legislation for Food Law and EU GMP (medicinal products). 

Duties and Responsibilities

  • Prepare dossiers for regulatory submission for THR licensed products through MHRA
  • Manage Pharmacovigilance in accordance with GMP and License requirements
  • Ensure regulatory compliance of Company Products and report any deviation to line manager.
  • Registration of Company products with the Vegan Society and maintenance of an approved product schedule
  • Manage the Soil Association registration process and assist with annual audit
  • Ensure all Company licences are maintained and updated as appropriate
  • Attend HFMA events and keep up to date with EU/UK legislation and MHRA guidelines regarding Food, Food Supplements, Herbal and Medicinal products
  • Company contact with local authority regarding Packaging Waste obligations
  • Contribute as required to other accreditations systems that the company may hold.
  • Manage the Trading Standard Visit / liaise with trading standards to close out any non-conformances observed.
  • Management of Gov.Gateway/DEFRA account.
  • Preparation of documentation for importation of goods.
  • Manage the Kosher / Halal registration process and assist with annual audits.
  • Manage the FDA registration process.
  • Manage Stability Protocols and product testing
  • Maintain effective and efficient documentation to ensure easy access for all

Other duties will include ,International Registrations, Supplier Management, Packaging Compliance, Quality Management System, Authority and Discretion.

Essential Skills  / Qualifications

  • Experience in QMS management within a pharmaceutical or food manufacturing environment.
  • Regulatory experience within a pharmaceutical or food manufacturing environment.
  • Accuracy and Diligence
  • Team-worker
  • Educated to degree level.
  • Experience in carrying out internal and external audits to meet cGMP standards

Competitive salary 

Job ref: 6989