Regulatory Affairs jobs

JOB DESCRIPTION

POSITION TITLE: REGULATORY AFFAIRS OFFICER

Reports to: Regulatory Affairs Manager

THE COMPANY

ECO Animal Health is a global organisation, headquartered in London (UK), specialising in veterinary pharmaceutical and biologicals for production animals.

ECO Animal Health specialises in high quality medicines for the treatment of important diseases in the livestock sector. ECO is dedicated to the research, development, and marketing of strong, existing brands, differentiated generics and innovative new solutions. ECO’s commitment to our customers is to provide them with products of a consistently high quality supported by customer-focused teams.

ECO Animal Health strives to provide best in class, scientifically proven, ethical solutions to optimise the health, productivity and wellbeing of livestock.

JOB PURPOSE

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.

SKILLS AND EXPERIENCE:

• 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