Position Details

Overview

Since January 2020, Phibro has created a new entity – Phibro Poland – in order to market current and future Phibro products directly to customers in Poland and other EU countries. Phibro’s sales today are focused around poultry vaccines and nutritional feed products for cattle and poultry as well. Going forward Phibro expects to introduce additional vaccines and nutritional feed products for poultry and dairy cattle. 

Regulatory Affairs Manager and Responsible Person – Veterinary Medicines Wholesale is responsible for:
•    Managing the product registration chain, compliance with regulatory authorities, regulatory affairs and company standards, maintenance of product licenses, and relevant LCM (life cycle management) activities.
•    Relationship with regulatory and governmental authorities in the country and region (selected EU countries). 
•    Promotional material review and release. 
•    Responsible for the planning and management of the budget for Regulatory Affairs activities in the country and region. 
•    Acting as QPPV’s local contact person

Duties & Responsibilities – Summary
Regulatory Affairs (RA)
•    Manage local and EU regulatory activities.
•    Liaise with authorities and distributors on registration matters.
•    Prepare and track VNRA/VARA/MAA submissions delegated by Global Vaccines RA.
•    Oversee national phase of EU procedures: translations, artworks, documentation.
•    Maintain regulatory records and databases.
•    Handle OPAD activities (availability, sales data, maintenance fees).
•    Prepare supporting documents for non-EU licensing.
•    Support GMP inspections, promotional material reviews, and product launches.
•    Monitor regulatory changes and represent company in industry meetings.
•    Act as local contact for the QPPV in Poland.
Responsible Person (RP) – Veterinary Medicines Wholesale Distributor
•    Ensure GDP compliance and quality system oversight.
•    Maintain operational documentation and staff training.
•    Coordinate recalls, complaints, and supplier/customer approvals.
•    Conduct audits, corrective actions, and report quality defects.
•    Execute regulatory decisions (quarantine, withdrawal) and control product flow.

Qualifications 

•    DVM or pharmacist.
•    At least 3 years’ experience in multinational pharmaceutical company or similar position.
•    Accomplishment of any postgraduate regulatory affairs course is welcome (eg. TOPRA).
•    Fluent in written and spoken English.
•    Computer literate (MS Office, including Teams)
•    Experience working in culturally diverse teams.
•    Planning skills and detail orientation.
•    Business acumen and project management skills.
•    Strong accountability and results oriented.