Director Regulatory Affairs and Affiliate Quality, Central and Eastern Europe

Locations under consideration include Zaventem (hybrid) , Warsaw and EU Remote.

Role Description

We are looking for a Director to lead the Regulatory Affairs and Affiliate Quality team in Central & East Europe (CEE: Poland, Czechia, Slovakia, Hungary, Baltics, Balkans and Ukraine). This role entails leading a team of 16 colleagues (7 of whom are direct reports) to ensure that the Regulatory Affairs and Affiliate Quality needs of the Commercial Operations are met. The position reports to the Senior Director Regulatory Affairs and Affiliate Quality, Europe and Middle East (EME). It will be based in Zaventem, Belgium, or Warsaw, Poland and will involve 10 - 20% European travel.

Responsibilities

• To lead the CEE Regulatory Affairs & Affiliate Quality Team, ensuring that Marketing Authorisations (product licences) are maintained, all products supplied to customers meet the relevant GMP/GDP and Zoetis internal requirements, and pharmacovigilance reporting obligations are met
• To be an active member of the Europe & Middle East Regulatory Leadership Team and an associate member of the Central & East Europe and Middle East (CEEME) Commercial Leadership Team
• To oversee the Geographic Expansion Procedure in CEE, balancing the needs of all stakeholders (Commercial, R&D and Global Manufacturing & Supply) and ensuring compliance with the agreed procedures and timelines
• To influence and ensure alignment of CEE Regulatory Affairs, Affiliate Quality and pharmacovigilance strategies and procedures with: corporate strategies, procedures and systems regulatory requirements of EU and National Authorities
• To actively manage Affiliate Quality Operations for Distributor Markets in the CEE region, including maintenance and execution of the Quality Management System (QMS)
• To support the CEEME Commercial Leadership Team in all matters concerning Regulatory Affairs, Affiliate Quality, and Pharmacovigilance, including but not limited to: Ensuring participation in regional and global projects, as required Representing Zoetis at Industry Associations Maintaining an awareness of changing legislation and guidance, and review of Public Affairs materials from a regulatory perspective Participate in team activities and travel, as appropriate
• Other specific duties and responsibilities as detailed in annual Objectives, or agreed with Line Manager

Requirements

• University degree in veterinary medicine, pharmacy, or biological/chemical science
• Regulatory, Quality and/or Pharmacovigilance experience in veterinary or human health (pharmaceuticals and/or vaccines)
• Experience in leading people
• Knowledge of the European animal health market and business environment would be an advantage
• Excellent communication skills in English

Full time Regular Colleague

Join Zoetis – and build your career with a global animal health company dedicated to supporting its customers and their businesses.

Why Zoetis

Zoetis has more than 60 years of experience in delivering innovative, high-quality products and services that benefit our customers.

Zoetis work environment

At Zoetis, we take pride in a collaborative spirit and high-performing environment where every colleague is given room to learn and grow.

Your opportunities at Zoetis

We invest in our people and offer diverse and exciting opportunities to make a difference in a growing global industry while shaping the future of animal health.

Results that matter

Our colleagues make an impact by working hand-in-hand with those who raise and care for animals to better understand and address the unique real-world challenges they face.