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).
Employer and Brand Information | 129 years of Happy Pets!
Brand History: Bob Martin was founded in 1892 by Robert Martin, who identified a need for supplements to give pets the nutrition and wellbeing they require. Since then, we have been manufacturing vet-quality healthcare solutions for nearly 130 years.
Employer: Pets Choice Ltd. is a family owned, fast growing FMCG manufacturer providing Pets and Wild Animals a variety of tasty treats, food and accessories. Pets Choice also holds the exclusive licence of the Bob Martin brand and ownership of the manufacturing site in Yatton, Somerset with a goal to continue the development, growth and reputation of the healthcare brand!
- 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 19 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.
- 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.
- A working knowledge of UK/EU regulatory affairs for pharmaceutical products, ideally with an insight for veterinary medicines. An understanding of biocidal product regulations (UK/EU) would be desirable.
- Excellent organizational and prioritization skills.
- Great attention to detail and excellent oral and written communication skills.
- Good working knowledge of Microsoft Office.
- Fluency in English. A basic knowledge of French or German or Spanish would be an advantage.
On offer from Pets Choice
- Office in a pleasant village location, south of Bristol.
- Flexible working options.
- Working in a small, friendly, supportive team covering a diverse range of projects - variety.
- Competitive salary, appropriately benchmarked and dependent on skills and experience.
- Career Path and opportunity to progress and develop as a QP.