ECO Animal Health

Compliance

• 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

Explore Regulatory Affairs Officer – UK, EU at ECO Animal Health. Review requirements and application details.

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Regulatory Affairs Officer – UK, EU