Regulatory Affairs Manager & Responsible Person

Warsaw

Nazwa pozycji Regulatory Affairs Manager & Responsible Person

Lokalizacja Warszawa, Warsaw, Masovian Voivodeship, Polska

Firma Phibro Middle East & Europe

Dodano 13. 12. 2025

Informacje o stanowisku

Regulatory Affairs Manager & Responsible Person

We’re hiring a Regulatory Affairs Manager & Responsible Person to join our Poland team in Warsaw!

Reporting directly to Country Manager, this hybrid‑role opportunity is ideal for a DVM or Pharmacist with at least 3 years of experience in regulatory affairs.

If you’re passionate about driving regulatory excellence, ensuring compliance, and making an impact in a dynamic environment – 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

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.
Planning and management of the budget for Regulatory Affairs activities in the country and region.
Acting as Pharmacovigilance (PV) Local Representative in Poland.

Regulatory Affairs (RA) Manager

Local and EU Regulatory Management.
Liaison with authorities (Poland/other EU Member States/EMA as required) and distributors in regards of registration matters.
Preparing VNRA (variation not requiring assessment) packages when delegated by Global vaccines RA, uploading to the UPD and tracking to finalisation.
Supporting the planning, submission and management of VRAs (variations requiring assessment) delegated by Global vaccines RA. Working closely with Global vaccines RA to successfully complete these actions according to the defined timelines.
Supporting the planning, submission and management of MAA (marketing authorisation applications) when delegated by Global vaccines RA, ensuring timelines are respected.
Managing the national phase of EU regulatory procedures. Preparing high quality translations of packaging texts (sometimes with the support of an external service provider), liaising with Global vaccines RA to ensure artwork and mock‑ups are accurately updated and arranging the collection/delivery of documents when necessary at the end of regulatory procedures.
Maintaining and updating RA records and internal systems.
Managing OPAD (other post authorisation data) activities: keeping product availability status up‑to‑date, supporting annual submission of volume of sales data, managing payment of annual maintenance fees etc.
Preparation of documents to support licensing in countries outside of the EU (e.g. CPPs, translations and notarised documents).
Assisting Global Quality with the organisation of GMP inspections of non‑EEA manufacturing sites by Polish competent authorities.
Reviewing and approving promotional materials.
Managing information and regulatory dossiers (confidentiality, protection, retention).
Monitoring regulatory changes (regulatory intelligence), attending industry meetings.
Supporting other departments with new product launches.
Acting as Pharmacovigilance (PV) Local Representative in Poland.

Responsible Person (RP) – Veterinary Medicines Wholesale Distributor

Oversight of GDP Compliance and Quality.
Ensuring compliance with GDP and supervising the quality system.
Controlling operational documentation and records.
Organising and overseeing staff training.
Coordinating product recalls and handling complaints.
Verifying and approving suppliers and customers.
Conducting internal audits and implementing corrective actions.
Reporting quality defects to the Chief Veterinary Officer.
Executing regulatory decisions on product quarantine/withdrawal.
Controlling product receipt and dispatch only to/from authorised entities.

Qualifications

DVM or pharmacist – a must.
At least 3 years’ experience in a multinational pharmaceutical company or similar position.
Accomplishment of any postgraduate regulatory affairs course is welcome (e.g. TOPRA).
Fluent in written and spoken English.
Experience working in culturally diverse teams.
Planning skills and detail orientation.
Business acumen and project management skills.
Strong accountability and results oriented.