Regulatory Affairs and Responsible Person
6 dni temu
Join our growing team in Warsaw
We're looking for a
Regulatory Affairs and Responsible Person
to take a key role in ensuring compliance and supporting our regulatory activities across Poland and the EU. If you have at least 3 years of experience in regulatory affairs, hold a
DVM or pharmacist degree
, and are ready for a hybrid position in a dynamic, global company — we'd love to meet you
Overview of Phibro
Phibro Animal Health Corporation is a U.S.-based company headquartered in Teaneck, New Jersey, listed on NASDAQ under the ticker PAHC. It operates globally in animal health, mineral nutrition, and specialty performance products. The company provides vaccines, medicated feed additives, nutritional supplements, and specialty chemicals for livestock, aquaculture, and companion animals. Phibro has a presence in over 80 countries, with strong positions in the U.S., Brazil, China, India, Mexico, and Europe. Its manufacturing network spans the U.S., Italy, China, Brazil, and Ireland, including a biotech center for vaccines. In FY2025, revenue reached approximately $1.3 billion, with 74% from the Animal Health segment. Mineral Nutrition remains a stable contributor, while Performance Products serve niche industrial markets. The company invests heavily in vaccine innovation and autogenous solutions, expanding capacity in key regions like Brazil. Strategic acquisitions, including products from Zoetis and MFA, have strengthened its portfolio and global reach. Phibro's strategy focuses on growth in emerging markets, diversification into companion animal health, and sustainable solutions for livestock production.
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.
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