Regulatory Affairs Officer

Job Description

Our client is one of the largest animal healthcare companies in the world and they have an exciting opportunity for a full time, Regulatory Affairs Officer to join their team initially on a 12 month Fixed-Term Contract. The Regulatory Affairs Officer is responsible for the maintenance of full pharmacovigilance systems in line with legislative and internal requirements, and standard operating procedures. You will liaise with relevant bodies and authorities in relation to any questions and/or the impacts of legislation. The successful candidate will be a qualified Vet (MRCVS) and/or hold the BSc Degree in Animal Science, with an interest in working within a regulatory role focused on continued legislative compliance.

In return, this business offers an excellent benefits package and the opportunity to be a part of a passionate, collaborative, and innovative team.

Key Responsibilities:

• Ensure full compliance of pharmacovigilance (PV) systems for both national and European law and in accordance with both local and Group Standard Operating Procedures (SOPs).
• Providing regulatory and quality support to Regulatory and Quality departments.
• Keep regulatory associated databases up to date with accurate and current information, both locally and centrally.
• Assist the Regulatory Affairs Manager with the submissions of variations.
• Ensure up-to-date datasheets for NOAH and the Animal and Plant Health Agency (APHA) are completed following new product introduction and variations.
• Provide support in documenting and filing complaints in the Company’s quality complaints system and assist in any delegated administrative tasks for the quality department.
• Responsible for the timely preparation and submission (where relevant) of the Company’s regulatory documentation, including Product Quality Reviews (PQR’s), Product Master Files and Anti-microbial returns (AMRs).
• Provide general administrative support to the Regulatory Affairs Manager and Quality Manager as required.

Skills and Experience:

• You must be either a qualified veterinary professional (MRCVS) or hold the BSc Degree in Animal Science.
• You will have exposure to regulatory work or a background in animal health with exposure and understanding of vet prescription drugs.
• Excellent attention to detail with strong accuracy skills.
• Intermediate knowledge of Excel and MS Office is essential.
• A proactive, can-do attitude and team player ethos is essential.

If you are interested in the above role, then please apply with an updated copy of your CV or call Joanna Middleton for more information on 01926 699272.