Regulatory Affairs and Responsible Person

6 dni temu


Warsaw Metropolitan Area, Polska Phibro Middle East & Europe Pełny etat 40 000 zł - 80 000 zł rocznie

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.


  • Warsaw Metropolitan Area, Polska GE HealthCare Pełny etat 80 000 zł - 120 000 zł rocznie

    Job Description SummaryProvides regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally. Interprets simple internal and external business challenges and recommends best...


  • Warsaw, Polska NATEK POLAND Pełny etat

    Regulatory Process Coordinator Miejsce pracy: Warszawa Technologies we use Expected SharePoint Microsoft Excel Microsoft Power BI ECMS system Power Apps AI tools About the project Join Natek as a Regulatory Process Coordinator and work for a top global pharmaceutical company! Location: Warsaw, Poland (3 days/week in the office) Duration: till the end of...


  • Warsaw, Polska NATEK Pełny etat

    Join Natek as a Regulatory Process Coordinator and work for a top global pharmaceutical company ! This roles supports Process Directors and Associate Directors in managing key processes and projects. The role focuses on activities related to process implementation, communication, compliance, performance tracking, and inspection readiness. You will...

  • Lead Person

    6 dni temu


    Warsaw, Indiana, Polska Bodycote Pełny etat 60 000 USD - 110 000 USD rocznie

     Lead Person   Bodycote offers:1,500 Sign-on Retention Bonus – N/A(Internal).Paid holidays and paid time off.401 (k) match, Medical, Dental, and Vision Plans for employees and families.Ability to work full-time, 40 hours per week.Shift/Hours: 1st Shift / 6:00 AM – 2:30 PM / Monday-Friday.Must pass a pre-employment drug screen and basic...

  • Regulatory Medical Writer

    4 tygodni temu


    Warsaw, mazowieckie, Polska Hirexa Pełny etat 16 zł - 800 zł

    Job Title: Sr Engineer (Life Science : Regulatory Medical Writing)Location: WarsawEmployment Type: Contract About Hirexa Solutions:Hirexa Solutions is a leading player in the recruitment ecosystem across the United States, United Kingdom, Europe, and India. As the fastest-growing next-generation provider of technology talent, we empower our clients to become...


  • Warsaw Metropolitan Area, Polska BeOne Medicines Pełny etat 50 000 € - 120 000 € rocznie

    BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.General DescriptionAccountable for regional study...


  • Gdansk Metropolitan Area, Polska Ocean Network Express Pełny etat 30 000 zł - 40 000 zł rocznie

    Job Purpose & Primary Job ResponsibilitiesIn this role, you will be responsible for the smooth running of the office with regard to facilities, office equipment and supplies. You will ensure proper invoice and documentation flow, coordinate in-and outgoing correspondence for the Management Team and the whole office, and organise company-wide events and...


  • Warsaw, Polska LeoVegas Group Pełny etat

    You will join the team of high-skilled Engineers in the Regulatory Reporting Team, responsible for maintaining and developing regulatory reporting functionality for the casino platform in many markets. The solution is mostly settled, but the team is working on the improvements and evolutions as well. YOU WILL BE RESPONSIBLE FOR: business requirements...


  • Warsaw Metropolitan Area, Polska A.P. Moller - Maersk Pełny etat 30 000 zł - 60 000 zł rocznie

    Indirect Tax Operations Junior SpecialistAs we deploy SAP S/4 Hana and other technologies, our vision for a radically transformed Indirect Tax (ITX) Compliance process is gradually becoming a reality. These innovative technologies enable Tax to be responsible for the complete process, from extraction of the required financial data to production of entity...


  • Warsaw Metropolitan Area, Polska LexisNexis Risk Solutions Pełny etat 40 000 zł - 80 000 zł rocznie

    Field Account Manager, CISLocation:Warsaw (hybrid / minimum twice a week in the office)This role requires regular travel to meet clients in person across the CIS region, supporting face-to-face relationship building and client engagement.About the Business:LexisNexis Risk Solutions empowers organizations worldwide to tackle complex challenges in Anti-Money...