Regulatory Affairs Manager EU

Job content

About Phibro Animal Health Corporation

Phibro Animal Health Corporationis a publicly traded organization with a rich history spanning nearly 100 years of service. The Company is a global manufacturer of medicated feed additives, feed ingredients, advanced nutrition solutions, vaccines and specialty chemicals for various industrial markets. Phibro’s revenues are in excess of $820 million, and are supported by over 1500 employees worldwide.

The Regulatory Affairs Manager EU is an integral part of our Regulatory Affairs team based out of our Belgium - Wavre site.

Reports to: Senior VP, Scientific & Regulatory Affairs with dotted line Senior Director, EU Operations

Job Overview:

The Regulatory Affairs Manager will be responsible for overseeing the registration, renewal, and ongoing regulatory compliance of veterinary medicinal products and feed additives within the European Union (EU). This role requires a deep understanding of EU regulatory frameworks and the ability to navigate the complex landscape of veterinary product registrations and renewals. The Regulatory Affairs Manager will work with cross-functional teams, leverage the use of external regulatory consultants and liaise with regulatory authorities, and ensure that all products comply with applicable EU laws and guidelines. In addition to regulatory oversight, the Regulatory Affairs Manager will act as the representative for the Wholesaler’s Dealers Authorization (WDA) for the organization, ensuring compliance with all relevant whole distribution regulations.

The Regulatory Affairs Manager will support the region for:

• All regulatory requests /inquiries from the authorities and/or customers.
• Regulatory support as required by manufacturing site in the region and /or CMO’s
• Training all EU employees on best practices and EUGXP compliance.

The regulatory affairs manager would be eligible to be the responsible person (RP) for the distribution of veterinary products from our distribution center in Belgium.

Key Responsibilities:

Regulatory Submissions and Approvals:

• Manage and oversee the preparation, submission, and approval of regulatory dossiers for veterinary medicinal products and feed additives across the EU. Work closely with external regulatory consultants and partners when required to ensure timely submission and approval of regulatory applications.
• Lead the coordination and submission of registration applications, including Marketing Authorization (MA) applications and renewals in accordance with EU regulations.
• Ensure timely submission of dossiers for new product registrations, variations, and renewals to maintain compliance with EU legislation (e.g., EMA, national regulatory bodies.

Regulatory Compliance and Maintenance:

• Ensure compliance with EU veterinary regulations, including the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and relevant directives for feed additives.
• Manage the lifecycle of veterinary products, including renewals, and work with the pharmacovigilance personnel on other post-approval obligations.
• Maintain regulatory compliance documentation and records for all EU veterinary product registrations and feed additives.
• Working closely with the Quality department to ensure the compliance of the quality system with the regulatory regulations

Regulatory Strategy and Guidance:

• Develop regulatory strategies for the EU market to support product registrations, renewals, and compliance for veterinary medicinal products and feed additives.
• Provide expert advice to cross-functional teams (R&D, quality, manufacturing, marketing) on regulatory requirements and best practices for veterinary products and feed additives in the EU. Collaborate with R&D, quality assurance, manufacturing, and commercial teams to ensure regulatory compliance is integrated into product development and launch activities.
• Keep abreast of evolving EU regulations and assess their impact on the company’s product portfolio. Monitor regulatory developments in the EU and proactively update internal teams on potential changes that could impact veterinary products and feed additives.
• Identify and assess regulatory risks related to product registrations and renewals, and develop mitigation strategies to ensure continuous product availability in the market.

Liaison with Regulatory Authorities:

• Act as the main point of contact with EU regulatory agencies (e.g., EMA, national competent authorities) for all veterinary product and feed additive registrations and renewals. Utilize and coordinate external consultants for this role, as applicable.
• Engage with regulatory authorities to ensure efficient review and approval of submissions and resolve any issues or questions that arise during the process.
• Participate in meetings, consultations, and regulatory inspections as required.

Documentation and Reporting:

• Oversee the preparation and submission of high-quality regulatory documentation, ensuring accuracy and compliance with EU guidelines.
• Develop and maintain comprehensive regulatory databases and trackers for all veterinary medicinal product registrations and renewals within the EU.

WDA Representation:

• Act as the organization’s representative for the Wholesale Dealer’s Authorization (WDA), ensuring compliance with all legal and regulatory requirements for wholesale distribution of veterinary medicinal products within the EU.
• Oversee WDA-related audits, inspections, and ensure compliance with Good Distribution Practices (GDP).
• Serve as the primary point of contact for regulatory bodies regarding WDA-related matters, including ensuring the correct storage, distribution, and handling of veterinary medicinal products.
• Act as a responsible person (RP) for the distribution of the veterinary products from the Belgian distribution center.

Qualifications:

Education:

• A DVM, Pharmacist or MS in veterinary, pharmaceutical or biomedical sciences, chemistry, biology, biochemistry is required.

Experience:

• 5+ years of experience in regulatory affairs, specifically within veterinary medicinal products in the EU. Experience with feed additives in the EU is desirable, but not required.
• Proven experience with EU veterinary product registration processes, including working with EMA and national regulatory authorities.
• Experience in preparing and managing regulatory dossiers, including initial registrations, variations, and renewals.

Skills:

• In-depth knowledge of EU veterinary regulations, including the Veterinary Medicinal Products Regulation (Regulation (EU) 2019/6) and relevant directives for feed additives.
• Strong project management skills with the ability to manage multiple regulatory submissions and renewals simultaneously.
• Excellent communication and interpersonal skills for effective interaction with regulatory authorities, internal teams, and external partners.
• Attention to detail and a strong understanding of regulatory documentation requirements.
• Proficiency in regulatory tracking systems and document management software.
• Fluency in English and French and/or Dutch is required; additional European languages are an advantage.
• Ability to work well in a fast-paced environment with deadlines driven by regulatory requirements and commercial needs.
• Occasional travel within the EU for meetings with regulatory authorities, conferences, and inspections.

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: Belgium - Wavre

Work Schedule: Monday - Friday (