Affiliate Regulatory Affairs Responsible Person – Hungary

Currently for Zoetis Hungary Kft. we are looking for candidates for the position of:

Affiliate Regulatory Affairs Responsible Person – Hungary

Location: Budapest

Role purpose:

Position’s main responsibility is to oversee and manage assigned regulatory related matters for Zoetis products in Hungary as well as to provide regulatory affairs and quality support to the local affiliate in order to help the markets achieve their revenue and growth targets. The position reports to General Manager Zoetis Hungary.

Responsibilities:

? Represent Zoetis to the Hungarian Competent Authorities for all product registration activities.

? Act as Deputy Responsible Person for Quality in compliance with Hungarian regulations.

? Obtain new product registrations and special import permits in line with local and regional strategies and renew or extend product registrations as necessary.

? Maintain product registration files, including submission of variation applications as necessary, with respect to changes in manufacturing, product testing and specifications, safety and efficacy information, and/or changes in local regulations.

? Preparation and/or approval of product labels and package inserts in accordance with the registration file.

? Archiving of regulatory documents, submissions, queries, approvals and correspondence, in accordance with Zoetis requirements.

? Ensure that local pharmacovigilance procedures are in compliance with corporate standards and local requirements.

? Review and approval of advertising and promotional materials, as it concerns compliance with the product registrations and local regulations.

? Oversight of Phase 3 a/b and Phase 4 clinical studies conducted by the local affiliate and ensure compliance with Zoetis guidance and local regulations.

? Develop and maintain knowledge of regulatory requirements at National and Regional level.

? Participate in colleague training (as trainer or trainee), as required.

? Participate and represent Zoetis in regulatory affairs activities within the National Animal Health Industry Federation (Hungarian Association of Innovative Veterinary Pharmaceutical Manufacturers’ Representation – ?ME).

Experience:

? Education: Pharmacist or Veterinarian.

? Minimum 3 years of experience as Regulatory Manager in a highly regulated business.

? Strong oral and written communication skills, enabling effective communication with all levels of the organization.

? Proactive and good organizational skills, and attention to detail.

? Negotiation and influence stills – the ability to influence others without express authority.

? Demonstrated strong analytical skills and the ability to integrate across multiple and varied business areas.

? Good command of English.

? Hungarian language is essential.

What we offer:

? the possibility to develop in recognized veterinary company in Hungary

? a wide range of benefits

If you meet the above criteria please submit your CV in English. Only selected candidates will be invited to participate in the recruitment process.