[Hiring] Regulatory Affairs Officer @Eco Animal Health

Role Description

Support product life cycle management. Responsible for managing the preparation, submission and tracking of applications/approvals of medicinal products, to ensure compliance with country specific regulations and seamless continuous supply of medicinal products to support animal welfare.

Responsibilities

• Manage global applications for assigned markets in accordance with local regulatory requirements.
• Manage regulatory compliance projects in assigned markets.
• Submit marketing authorisation applications and post-authorisation procedure applications via the Centralised Procedure, Mutual Recognition Procedure and National Procedures to European Regulatory Authorities.
• Submit marketing authorisation applications and post-authorisation procedure applications to the Veterinary Medicines Directorate (VMD-UK).
• Submit marketing authorisation and post-authorisation procedure applications to global local regulatory agencies.
• Liaise with Regulatory Agencies, local regulatory representatives, affiliates, contract manufacturing sites, contract laboratories and internally with quality, technical, operational and marketing departments to ensure smooth running of the regulatory department.
• Deal with day-to-day internal and external regulatory enquiries.
• Manage artwork updates including annotation, revision and signing off labelling artwork pdf files in Eco’s electronic artwork management system (ESKO AMS).
• Raise change controls for regulatory changes in an electronic quality management system to reflect all global and EU changes.
• Implementation and management of regulatory information management system.
• Support with authoring, review and authorizing regulatory Standard Operating Procedures.
• Ensure compliance with company Standard Operating Procedures (SOPs), global regulations and guidelines.
• Being up-to-date with EU requirements, local regulatory requirements and VICH guidelines.
• Request Export Certificates from VMD, CPPs from EMA, samples, and Certificate of Analysis.
• Manage application payment invoices.
• Update the NOAH/AMTRA Compendium Datasheets for centralised/decentralised products - using a web editor - to reflect the latest published Product Information.
• Provide regulatory support to the Product Development Team for allocated projects (e.g regulatory strategy, Scientific Advice application, pre-submission meeting request, eligibility request, letter of intent request, initial marketing authorization application).
• Operate electronic submission portals (i.e. Union Product Database, IRIS) and any publishing tools for electronic filings.
• Upload regulatory submission documents as per local procedures.
• Assess regulatory intelligence to identify any impact upon internal processes and projects.
• Undertake gap analysis of key technical documents and identify potential challenges.
• Assist with projects to meet business needs and changes in the regulatory environment.
• Assist with other duties and/or special projects as requested.

Qualifications

• A degree in Immunology, Biochemical engineering, Biotechnology or related field is required.
• Relevant experience in 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.