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Regulatory Affairs Manager

£40,000 per annum

United Kingdom

Do you have extensive knowledge of regulatory affairs?

Do you want to work alongside a dedicated and successful team?

Role Summary

The Tangerine Group currently comprises five companies involved in the animal health sector. Agri-Lloyd and Farmsense supply nutritional supplements to the farm sector; Carr, Day and Martin provide an extensive range of equine products on a global basis and Day, Son and Hewitt provide an extensive range of equine nutritional supplements. VetPlus, the veterinary division of the company is currently the leading supplier of veterinary nutraceuticals within the UK. In addition, it has 4 international subsidiaries plus extensive European and Asian distribution with an active expansion plan requiring registration of products in several international markets.

The continued growth and expansion of the Tangerine group has created a vacancy for a Regulatory Affairs Manager, to support the Tangerine group companies in the registration of a range of licensed veterinary products, animal nutritional supplements and equine products for the UK and international markets.

This will include:

  • Providing regulatory knowledge on ingredient and product changes and maintenance issues.
  • Co-ordination of regulatory documentation to support product changes and registration in both the UK and international markets.
  • Provide appropriate summaries and options resulting from changes to regulations.
  • Provide training to staff in regard to regulatory changes and for mandatory revisions.
  • Lead the organisations Pharmacovigilance requirements.

The Regulatory Affairs Manager will work directly with various peers, senior management (especially the Heads of Regulatory Affairs, Quality and Research and Development), customers and company Directors to support the organisations objectives and obligations.

Working closely with the Head of Regulatory Affairs you will be tasked with implementing and managing the regulatory status for all products within the Tangerine Group, in particular:

Licenced Products

  • Prepare and progress variations to the company’s manufacturing authorisations to ensure they are maintained (ManA & ManSA).
  • Collate, prepare and progress veterinary Medicine renewals and variations for existing Marketing Authorisations.
  • Work closely with the Quality department to ensure that any changes are made in line with regulatory requirements.
  • Act as the Company’s QPPV for Vetplus and Carr & Day & Martin, which includes the preparation and submission of PSURs and submission of SAEs to the Competent Authority (VMD) (if experience permits).
  • Act as a consultant QPPV for Gibraltar (UK) Ltd on behalf of the product distributor Farmsense which includes the preparation and submission of PSURs and submission of SAEs to the Competent Authority (VMD) (if experience permits).

Feed / Nutraceutical Products

  • Ensure that all product labels, literature and packaging complies with the appropriate legislation (e.g. Equine Prohibited Substances, Feeding Stuffs Regulations, Veterinary Medicines Regulations guidelines) in both UK and international markets.
  • Perform regulatory checks on new and updated labels.
  • Maintain a system to track all relevant stages of registration and licensing.

Export Markets

  • Perform continuous analysis on existing dossiers and update regulatory compliance documents to ensure all product registrations are current and compliant in each country.
  • Produce regulatory dossiers for registration and export of products to international markets.
  • Provide continuous support to the International Distributors.
  • Present required documentation for international orders (i.e. Certificates of Analysis, Health Certificates, and Certificates of Free Sale.
  • Maintain a system to track all relevant stages of registration and licensing.

Miscellaneous

  • Ensure Safety Data Sheets (MSDS) are up to date and in line with current regulations for all products within the Tangerine Group.
  • Regular updates on regulatory changes and developments in the UK and current markets that impact the company to the Head of Regulatory Affairs.
  • Train staff regarding regulatory changes and for mandatory revisions.
  • Provide direction, mentoring and manage less experienced staff.

Occasional Duties

  • Attend staff meetings and training as required.
  • Occasional travel to other sites may be required.
  • Meet with relevant governing bodies/consultants.
  • Deputise for Head of Regulatory Affairs at Senior Management meetings as required.
  • Carry out any other duties as are within the scope, spirit and purpose of the job, the title of the post and it’s grading as requested by the line manager.

About You

  • Bachelor of Science degree (Pharmacy/Chemistry or related discipline) is essential.
  • 6+ years’ experience in Regulatory Affairs, ideally in Veterinary Medicine and Animal Feed Regulations.
  • Knowledge of biocides (preferable).
  • Knowledge of NPD and/or formulating products (preferable).
  • Experience of working with regulatory bodies such as VMD or MHRA.
  • Knowledge and understanding of the role and responsibility of a Qualified Person for Pharmacovigilance, as it relates to Veterinary products (preferable).
  • Experience of product registration in international markets.
  • Good interpersonal skills.
  • Excellent time management skills.
  • Proven project planning skills.
  • Previous man management experience.
  • Strong written and verbal communication skills.
  • Highly developed interpersonal and team skills.
  • Experience of dealing with external customers.
  • Ability to work under pressure to meet deadlines.
  • Strategic thinking individual with the ability to work under own initiative to meet deadlines.
  • Able to adapt to change and new circumstances.
  • Able to work under pressure handling the multiple and complex tasks involved in detailed regulatory work.
  • Capable of understanding the needs and priorities of the business and translating these into appropriate regulatory actions.
  • Good quality IT skills to include Microsoft Word, Excel, PowerPoint and Outlook.


Tangerine Holdings Limited
SectorAgronomy
Job TypePerm
RecruiterThird Party Employer
Job ID48947

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