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

 

 

Any unsolicited resumes sent to Zoetis from a third party, such as an Agency recruiter, including unsolicited resumes sent to a Zoetis mailing address, fax machine or email address, directly to Zoetis employees, or to Zoetis resume database will be considered Zoetis property. Zoetis will NOT pay a fee for any placement resulting from the receipt of an unsolicited resume.

Zoetis will consider any candidate for whom an Agency has submitted an unsolicited resume to have been referred by the Agency free of any charges or fees. This includes any Agency that is an approved/engaged vendor but does not have the appropriate approvals to be engaged on a search.

 

 

Notice: Zoetis Recruiters will contact candidates via email from an address ending in @zoetis.com and may also initially connect with candidates through LinkedIn, including LinkedIn InMail. Zoetis does not use Gmail, Outlook, Yahoo, or other web-based/generic email domains to communicate about job opportunities, interviews, or offers of employment. If you receive a recruitment-related email message claiming to be from Zoetis that does not come from @zoetis.com, please treat it as suspicious. For your security, do not reply, click links, open attachments, share personal or financial information, or send money in response to unexpected or questionable recruitment communications.