Regulatory Affairs Manager and Responsible Person

About Phibro Animal Health CorporationPhibro 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 Manager and Responsible Person is an integral part of our Regulatory Affairs team based out of our Poland site.Position DetailsRegulatory 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. Planning and management of the budget for Regulatory Affairs activities in the country and region. Acting as Pharmacovigilance (PV) Local Representative in PolandDuties & ResponsibilitiesRegulatory Affairs (RA) Manager:Manage local and EU regulatory activities and liaise with authorities/distributors.Prepare VNRA/VRA/MAA submissions and track progress with Global Vaccines RA.Manage national EU procedure phases: translations, artwork updates, documentation.Maintain RA records and systems; manage OPAD activities.Prepare documents for non-EU licensing.Support GMP inspections of non-EEA sites.Review/approve promotional materials; manage regulatory dossiers.Monitor regulatory changes and support product launches.Serve as PV Local Representative in Poland.Responsible Person (RP) – Veterinary Medicines Wholesale DistributorEnsure GDP compliance and oversee Quality System.Manage documentation, training, and internal audits.Handle recalls, complaints, and supplier/customer approvals.Report quality defects and execute regulatory decisions.Control product receipt/dispatch to authorized entities only.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 EmployerAll 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)