Regulatory Affairs Manager

Position Overview:

This is a varied role in the Veterinary and Animal Health industry, with the chance to participate in, and be the go-to regulatory person for a wide spectrum of projects including product development and product improvement.
This role also offers a career path and study to become a Qualified Person (QP).

Location:

Yatton, Somerset

Company Overview:

Pets Choice is a leading Pet Food and Pet Products Manufacturer with offices and production facilities based in Lancashire, Somerset and South Wales. The Pets Choice brand portfolio includes; Webbox, Bob Martin, TastyBone, Meatiful, Spike’s, WildThings, Feathers & Beaky and Vitakraft. Each brand offers a unique insight into animals from dogs to ducks and produces high-quality products that cater to a wide variety of pet consumer needs.

Role:

  • Study scientific and legal (regulatory) documents; offering summaries to colleagues.
  • Keep up to date with changes in regulatory legislation and guidelines. Advise team members on changing regulations and compliance requirements.
  • Gather, evaluate, organise, manage and collate information in a variety of formats.
  • Prepare dossiers for regulatory submissions; Marketing Authorisations and Variations. Being active in responding to, and negotiating around questions concerning these. Ensure submissions comply with applicable regulations and guidance documents.
  • Ensure compliance with EU and UK Regulations, as operated by the Veterinary Medicines Directorate, Health and Safety Executive and the Medicines and Healthcare products Regulatory Agency (MHRA) for the UK, and other agencies within the EU.
  • Maintain familiarity with company product ranges, particularly details on product labelling. Help the team to write comprehensible, user-friendly, clear product information leaflets and labels. Ensure that label content and layout accord with what is defined within the Marketing Authorisation.
  • Interact with the Formulation Development team, and the Quality team, to ensure that there are clear communications concerning required data, e.g. stability, to support regulatory aspects of product development and dossier / variation applications preparation.
  • Pets Choice Ltd. is active with Product Types 2, 3, 18 and 10 biocidal products, in both UK and EU. Use appropriate training and support to enable existing national registration schemes to be exploited, as well as being pivotal in BPR dossier development / negotiating with the regulators.
  • Assist with regulatory support for maintaining the Manufacturing Authorisation (ManA)
  • Active in regulatory audits and inspections.
  • Ensure that specific regulatory changes are communicated to the QMS Manager to ensure appropriate Change Control.

Key attributes and skills:

  • Bachelor's degree in a Life Sciences field.
  • Regulatory and QA experience
  • At least two years’ experience preparing, reviewing, and submitting regulatory documentation to Regulatory Agencies, including formulating responses to queries.
  • Knowledge of regulatory guidelines in UK and EU for medicines. Knowledge of veterinary and biocidal products is desirable.
  • Excellent organizational and prioritization skills.
  • Great attention to detail and excellent oral and written communication skills.
  • Good working knowledge of Microsoft Office.

Package:

  • Office in a pleasant village location, south of Bristol.
  • Flexible working options.
  • Competitive salary, appropriately benchmarked and dependent on skills and experience.
  • Career Path and opportunity to progress and develop as a QP.

If you would like to apply for this position, please send your cv to recruitment@petschoice.co.uk