Regulatory Affairs Officer – UK, EU

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🔥 0 minutes ago

🇬🇧 United Kingdom – Remote

💵 £30k - £45k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

👻 Ghost score 0%

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ECO Animal Health

WebsiteLinkedInAll Job Openings

51 - 200 employees

🏥 Healthcare

🍽️ Food & Beverage

🧬 Biotechnology

Healthcare • Food & Beverage • Biotechnology

ECO Animal Health is a publicly listed UK-headquartered animal-health biotechnology company that develops, registers and markets branded veterinary pharmaceuticals and biologicals—particularly proprietary antibiotics and vaccines—for pigs and poultry worldwide. The company focuses on prevention and treatment of economically important respiratory and enteric diseases, emphasizes R&D and sustainable solutions, and operates through a global network of partnerships and distributors in over 70 countries.

📋 Description

• Support product life cycle management • Manage global applications for assigned markets in accordance with local regulatory requirements • Manage regulatory compliance projects in assigned markets • Submit marketing authorisation and post-authorisation applications through Centralised, Mutual Recognition, National, VMD-UK and global local regulatory procedures • Liaise with regulatory agencies, representatives, affiliates, contract sites, laboratories and internal departments • Handle day-to-day internal and external regulatory enquiries • Manage artwork updates and labelling artwork approvals in ESKO AMS • Raise change controls for regulatory changes in the electronic quality management system • Implement and manage the regulatory information management system • Support authoring, review and authorization of regulatory SOPs • Ensure compliance with company SOPs, global regulations and guidelines • Maintain knowledge of EU, local regulatory requirements and VICH guidelines • Request Export Certificates, CPPs, samples and Certificates of Analysis • Manage application payment invoices • Update NOAH/AMTRA Compendium Datasheets using a web editor • Provide regulatory support to Product Development projects, including regulatory strategy and applications • Operate electronic submission portals such as Union Product Database and IRIS • Upload regulatory submission documents according to local procedures • Assess regulatory intelligence and identify impacts on processes and projects • Undertake gap analyses of technical documents and identify potential challenges • Assist with projects and other duties as requested

🎯 Requirements

• A degree in Immunology, Biochemical engineering, Biotechnology or related field is required • Relevant experience vaccine development or manufacture is desired • Experience in the animal health industry preferable but training will be provided • Experience of electronic data management systems required • Strong organisational skills and the ability to work well both within a multi-disciplinary team and independently • Focused on quality output with strong attention to detail • Clear communication in written and spoken English