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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in regulatory compliance management, including submission processes and adherence to local and global regulations. Proficient in managing regulatory information systems and supporting product development projects within the animal health industry.
Highest-signal resume keywords
Regulatory Compliance ManagementElectronic Data Management SystemsRegulatory Submission ProcessesAttention to DetailClear Communication in English
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory Life Cycle ManagementMarketing Authorisation ApplicationsArtwork Updates ManagementRegulatory SOP AuthoringGap Analysis of Technical DocumentsRegulatory Intelligence AssessmentChange Control ManagementRegulatory Information Management SystemVICH Guidelines KnowledgeApplication Payment Management
Soft Skills
Strong Organisational SkillsAbility to Work IndependentlyTeam Collaboration
Tools & Technologies
ESKO AMSUnion Product DatabaseIRISNOAH/AMTRA Compendium Datasheets
Industry Keywords
ImmunologyBiochemical EngineeringBiotechnologyVaccine DevelopmentAnimal Health Industry
About the role
Key responsibilities & impact- 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
What you’ll need- 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