Regulatory Affairs and Responsible Person

About Phibro Animal Health Corporation

Phibro Animal Health Corporation is a publicly traded, global organization with a rich history in animal health and nutrition as a manufacturer and marketer of medicated feed additives, vaccines, nutritional specialty products, and mineral nutrition. We strive to be a trusted partner with livestock producers, farmers, veterinarians, and consumers who raise or care for farm and companion animals by providing solutions to help them maintain and enhance the health of their animals.

Phibro is a diversified company in manufacturing and marketing products for ethanol performance, microbials for plants, home and industrial applications, and specialty chemicals for various industrial markets. In addition to, Phibro's revenues are in excess of $1 billion and are supported by over 2,300 employees worldwide.

At Phibro, people are our greatest asset. We strive to develop a diverse workforce that fosters an environment where people feel supported in openly sharing their creativity and skills that allows them to be the most successful that they can be.

If you are interested in working for Phibro and feel that you do not meet all qualifications, we encourage you to apply as you might be the right candidate for this role or other positions.

The Regulatory Affairs and Responsible Person is an integral part of our Regulatory Affairs team based out of our Poland site.

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.

To learn more about Phibro Animal Health's competitive benefits package, please click here: Phibro Benefits.

Phibro is an Equal Opportunity Employer

All qualified applicants will receive consideration for employment without regard to race, national origin, gender, age, religion, disability, sexual orientation, gender identity, veteran status, marital status or any other characteristics protected by law.

Business Unit: Animal Health & Mineral Nutrition

Division: Animal Health & Nutrition

Department: Regulatory Affairs

Location: Poland

Work Schedule: Monday - Friday (40 Hours)