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Regulatory Affairs Manager

Leicestershire   •  Negotiable  •  Permanent, Full time

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

The full job description will be shared upon successful application.

You must be eligible to work in the UK. Learn more

  • Agency: Cranleigh Scientific
  • Reference: 69891
  • Posted: 19th July 2021
  • Expires: 16th August 2021

Cranleigh Scientific

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