POSITION SUMMARY
The role will be based at our International HQ in Cherrywood, Dublin. The Regulatory Coordinator manages the process of obtaining and maintaining the marketing authorisations for Zoetis products, which set the licensing conditions by which a product can be sold. Work internally with the EU regulatory affairs team to gather information, documentation and details necessary for the application. Ensure compliance of packaging material used to market Zoetis products. Support the Regulatory Affairs Manager on handling issues of product quality in the marketplace and warehouse, managing immediate quality concerns and putting in place corrective actions for the future.
POSITION RESPONSIBILITIES
Business Unit Support
- Provide competent and professional administrative support to commercial operations and business support services as required.
- Plan, organise and prioritise requests in order to meet deadlines, team expectations and own workload.
- Maintain high standards of business conduct and compliance, adhering particularly to Pharmacovigilance Policy, Global vet Policy, Zoetis values and local codes of practice Provide support in quality related tasks
Licence Renewals, Variations & New Applications
- Gathering application documentation, and help preparing submission to the regulatory authorities, monitor progress against set timelines, take appropriate action to minimise delays and anticipated difficulties.
- Update regulatory documentation following issue of licences Support Regulatory Manager and VMRA in filing, progressing and completing new European applications.
- Ensure national requirements are communicated to VMRA and communicate with VMRA on the need for specific variations
Artwork
- Ensure artwork complies with licences
- Support the execution of artwork change campaigns to align with manufacturing production schedules to maximise impact of new packaging introduction and minimise packaging write off costs
- Support Zoetis' participation in the publication of Animal & Plant Health Association (APHA) Compendium
Maintenance of Regulatory Database
- Update and maintain databases to ensure information is accurate, renewal dates are correct and information is readily communicated to VMRA and all interested parties
- Use and support all information systems needed to facilitate the Regulatory role
- Maintenance of product database
- Maintenance of archive
ORGANIZATIONAL RELATIONSHIPS
Relationships
Work in constant partnership with internal stakeholders. Nurture productive relationships built on common goals Support the regulatory team in the Northern Europe Cluster when beneficial or necessary Be a contributing voice in the Regulatory team when inputting into country wide plans and programs Contribute to the success of the function by role modelling best practice with colleagues, proactively welcoming ideas, sharing successes and enabling the team to do the same across the business
Compliance
Work in collaboration with General Manager and Regulatory Affairs Manager on the systems to monitor and improve the approval process Maintain high standards of business conduct and compliance, adhering particularly to Pharmacovigilance Policy, Global Vet Policy, Zoetis values, travel & expenses policy and local codes of practice Check compliance of each printed packaging component created from the product information translations before it is placed on the market
EDUCATION AND EXPERIENCE
- Preferably a Bachelor's or Master's degree in related scientific discipline: Pharmaceutical Technology, Veterinary, Biology, Data Management, Logistics & Supply Chain, etc.
- Minimum 3-5 years knowledge from similar positions within the pharma industry or related
- Experience of the workings and practices of industry bodies e.g. APHA, HPRA, DAFM
- Detailed understanding of relevant European legislation, licensing and related practices and laws is beneficial
- In-depth knowledge of local and EU Regulations and guidelines
- Experience using Quality Management Systems is beneficial IT literate. Able to use standard business software, communication tools and quality management systems
- Stakeholder management skills: Communication, relationship building
- Positive, proactive, and pragmatic with an entrepreneurial mindset
- Excellent knowledge of spoken and written English
- High standing, with excellent communication
TECHNICAL SKILLS REQUIREMENTS
Capability in, or potential to develop.
- Analytical thinking with attention to detail and problem-solving skills
- Expectational communication skills; written and verbal
- Organised and effective ways of working; recording of data, prioritising, time management
- Creative thinking and application in the business
- Don't allow regulation to negatively impact the customer.
- Explore options and pursue solutions until the customer is satisfied
PHYSICAL POSITION REQUIREMENTS
- Occasional travel required within Republic of Ireland and overseas
About Zoetis
At Zoetis, our purpose is to nurture the world and humankind by advancing care for animals. As a Fortune 500 company and the world leader in animal health, we discover, develop, manufacture and commercialize vaccines, medicines, diagnostics and other technologies for companion animals and livestock. We know our people drive our success. Our award-winning culture, built around our Core Beliefs, focuses on our colleagues' careers, connection and support. We offer competitive healthcare and retirement savings benefits, along with an array of benefits, policies and programs to support employee well-being in every sense, from health and financial wellness to family and lifestyle resources.
Diversity, Equity & Inclusion
Connected to our purpose and Core Beliefs, at Zoetis, we lead with inclusion. Our Diversity, Equity & Inclusion (DE&I) focus helps create an environment where each colleague can thrive. Our commitment to DE&I begins with our leadership team of diverse backgrounds, experiences and ethnicities, and it is demonstrated in our support of our colleagues and the animal health industry. We have nine colleague resources groups whose members spread awareness, foster inclusivity and make a positive impact on our business and communities.
Our commitment to advancing Diversity, Equity and Inclusion has earned us recognitions as a 2024 Catalyst Award recipient and a Top 50 Company for Workplace Fairness by Fair360 (formerly DiversityInc). Zoetis has also been named a Best Place to Work for LGBTQ+ Equality, a Best Company for Working Parents, a Top Company for Executive Women, among many others. Learn more here.
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