Regulatory Affairs Manager and Responsible Person Job Details | Phibro Animal Health

Phibro Animal Health Europe; Województwo mazowieckie; On-site; PLN 211,000 - 296,000; Full time

Job summary

A global animal health company is seeking a Regulatory Affairs Manager in Poland, responsible for managing regulatory activities, ensuring compliance, and acting as Pharmacovigilance Local Representative. Applicants should have a DVM or pharmacist qualification, at least 3 years’ experience in the pharmaceutical field, and be fluent in English. This full-time role offers a diverse work environment and the opportunity to contribute to animal health solutions.

Benefits

Competitive benefits package

Qualifications

• At least 3 years’ experience in a multinational pharmaceutical company or similar position.
• Computer literate, including Teams.
• Experience working in culturally diverse teams.

Responsibilities

• Manage local and EU regulatory activities and liaise with authorities/distributors.
• Prepare VNRA/VRA/MAA submissions and track progress with Global Vaccines RA.
• Ensure GDP compliance and oversee Quality System.

Skills

Fluent in written and spoken English

Planning skills and detail orientation

Strong accountability and results oriented

Business acumen and project management skills

Experience working in culturally diverse teams

Education

DVM or pharmacist

Postgraduate regulatory affairs course (e.g. TOPRA)

Tools

MS Office

Job description

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.

Position Details

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

Duties & Responsibilities

Regulatory 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 Distributor

• Ensure 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 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)