Regulatory Executive

4 weeks ago

United Kingdom Zoetis Full time
Regulatory Executive (Contractor) 9-12 months (RE24) Leatherhead, England

Job Purpose

A core member of the Regulatory and Quality team, managing and maintaining Marketing Authorisations for Northern Ireland in line with business goals and legal requirements in the UK and EU.

Core Responsibilities

Licence Variations
- Manage all applications for Northern Ireland 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
- Liaise with Ireland Regulatory and Commercial Teams to ensure licence variations are submitted and communicated in accordance with the submission plan
- Address all questions from UK regulatory agencies on all applications for Northern Ireland in collaboration with business colleagues
- Update regulatory documentation following issuance of licences
- 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 EU and UK Veterinary Medicines Regulations
- Plan and execute artwork changes in line with business plan for transition of Marketing Authorisations to Zoetis Belgium
- Ensure artwork changes following marketing authorisation transfers are completed and implemented within 12 months

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

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
- Work closely with Ireland Regulatory and Commercial Teams
- 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
Training & Qualifications - Batchelor’s degree in related discipline desired; veterinary, science
- 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

Name:

Please include your first and last name.

Email: @

Phone:

Please include your country code.

CV / Resume:

Yes, I am currently eligible to work (work permit/visa/citizenship) in the country to which I am applying. No, I am not currently eligible to work (work permit/visa/citizenship) in the country to which I am applying.

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