AddressJob Purpose
A core member of the Regulatory and Quality team, managing and maintaining Marketing Authorisations in line with business goals and legal requirements in the UK.
Supporting and applying of the Quality Management System (QMS) and resolving quality related issues.
Core Responsibilities
Licence Renewals, Variations & New Applications
- Manage all applications through the licence process; gathering application documentation, submission to the UK regulatory authorities, monitor progress against set timelines, take appropriate action to minimise delays and resolve any issues and answer agency questions
- Work with Zoetis Veterinary Medicine Regulatory Affairs (VMRA) to ensure production of accurate documentation for timely submission to regulatory agency
- Address all questions from UK regulatory agencies on all applications in collaboration with global, R&D and business colleagues
- Update regulatory documentation following issue of licences
- Action renewal and variation requirements for new product acquisitions with VMRA. Be responsible for smooth transition into the Zoetis portfolio
- Support filing, progressing and completing procedures. Ensure national requirements are communicated to VMRA and adhered to
- Remain aware of current regulatory environment and, where affected, ensure Zoetis complies.
Artwork
- Ensure artwork complies with UK licences and veterinary medicines’ regulations
- Plan and execute artwork change campaigns to align with manufacturing production schedules to maximise impact of new packaging introduction and minimise packaging write off costs
- Ensure artwork changes following licence renewals and variations are made in line with published timelines
- Maintain adequate processes to ensure monitoring of artwork changes
- Manage the packaging process for new product acquisitions and third-party products into our portfolio ensuring continuous supply and timely introduction of new packaging
Maintenance of Regulatory Database
- Update and maintain databases to ensure information is accurate, renewal dates are known and planned and information is readily communicated to all interested parties
- Maintain IT systems eg SAP, so stock is not blocked for sale and resolve any issues as needed
Quality
- Support and help manage the QMS and partner the business to make documented procedures available to all that require them
- Help ensure colleagues are appropriately trained on all necessary procedures
- Attend Quality meetings for critical product quality issues, representing the businesses
- Prepare required documentation for product quality complaints that require Quality/ Market Action
Relationships
- Develop a broad network of contacts – opinion leaders, key influencers, industry consultants, industry bodies – and maintain good working relationships with them
- Work in partnership with internal stakeholder, nurturing productive relationships built on common goals
- Become and be recognised as a regulatory and Quality expert, contributing to country and cluster programmes
- Model best practice with colleagues, proactively welcoming ideas, sharing successes and enabling the team to do the same across the business
- Use you network to influence the environment for the benefit the business
Key Skills
- Analytically minded with strong attention to detail and problem-solving skills
- Exceptional communication skills; written and verbal
- Exceptional relationship management, interpersonal skills and influencing abilities
- Effective time management, prioritisation and organisational abilities
- Work effectively to deadlines and under time pressures showing multi-tasking and the ability to meet overlapping deadlines
- Strong business and financial acumen with a keen commercial mind
- Ability to work well under own direction as well as within a team environment
Behaviours
Our Colleagues make the difference
- Express your own opinion whilst remaining factual and respectful
- Find innovative solutions in challenging environment within legal and compliance restrictions
Always do the right thing
- Ensures that professional standards and the company’s policies and procedures are upheld
- Help build the reputation of our brand by understanding and supporting the things that we stand for
Customer obsessed
- Challenge yourself to consider the impact on the end customer with every decision, every action
- Ensures that systems and processes make it easy for customers to do business with Zoetis
Run it like you own it
- Be an enabler of action. Say ‘no’ when you have to, but try to say ‘yes’ often
- Deliver on your commitments to colleagues and stakeholders. Do what you say you’ll do – and quicker, and better
We are one Zoetis
- Give colleagues in the business timely information and support that helps them to deliver their role
- Discover what’s going on around the business and get involved
- IT literate. Able to use standard business software, communication tools and Quality management systems
Experience
- Experience in an animal health (regulatory affairs / quality idealy ) or other regulated industry
- Experience of the workings and practises of industry bodies e.g. VMD, NOAH desirable
- Understanding of regulatory and Quality environment and trends
Travel Requirement
- Very occasional travel required
