Regulatory Specialist

Experiencing together a unique human adventure Animal health is key to the health of the planet. Working at Virbac means taking part in a unique human adventure in which the engagement of each individual contributes to its evolution.

Encouraging internal mobility between positions and countries, offering individual development plans and building a partnership based on trust between managers and employees are as many perspectives of motivation for our teams. We also offer them a work environment conducive to exploring new territories and balancing their professional and personal lives.

Finally, fostering their engagement to animal health also means listening to them and helping them to acquire new skills, preparing them for the challenges of tomorrow and encouraging them to contribute to an ever more responsible approach to our business. Regulatory Affairs Specialist Virbac Animal Health is looking for a Regulatory Affairs Specialist to join our team.

Aligned with Virbac’s strategic goals, this role is responsible for maintaining regulatory compliance and ensuring timely, effective submissions to regulatory agencies. Key Responsibilities: Collaborate with Marketing and Communications to coordinate A&P reviews. Partner with Pharmacovigilance to manage DER updates. Work alongside CMC Regulatory to handle drug listing updates.

Support the Project Management Operations (PMO) Labeling Project Team (LPT) in evaluating and submitting labeling projects.

Bachelor’s Degree is required but Master’s Degree is preferred 1 to 3 years of previous experience in Regulatory is preferred Benefits: 13 Company paid Holidays; 5 Floating Holidays (prorated); 15 vacation days (prorated); 5 floating holidays (prorated); 6% 401k match; competitive pay and bonus opportunity; growth opportunities within the department and much more!

Area of accountability no.1: Regulatory Submissions Main activities: - Compile and author submissions to meet regulatory requirements for the A&P, DERs, Drug listings, and Labeling projects as applicable. - Evaluate risks to develop regulatory strategies. - Ensure the preparation of drug A&P, DERs, Drug listings, and labeling projects are processed and submitted to the agency, as applicable, completely and efficiently, meeting project deadlines. - Collect and collate documentation needed to complete the creation of submissions. - Correspond with the agency as needed for the projects and tasks. - Liaison with the U.S.

Regulatory Managers as needed for the A&P reviews, DERs, Drug listings and labeling projects. - Liaison with the Distributors as needed for A&P reviews, DERs, Drug listings, submissions, and labeling projects as applicable. - Research and review the regulations, guidances, and industry group recommendations, as applicable, in order to develop into the Regulatory specialist role.

Expected results: To develop comprehension and application of the regulations and guidances for the labeling, A&P, DERs, and Drugs listings. Review, coordinate, provide feedback and develop regulatory strategies on the A&P, DERs, and Drugs listings, and labeling as applicable. Submit accurate, timely, and complete documents to regulatory agencies, as applicable.

Continue to develop a positive working relationship with the agencies. Area of accountability no.2: Quality Control Main activities: - Liaison with the U.S.

Regulatory Managers, Distributors, and other external and internal customers to meet the labeling project, A&P, DER, and Drug listing requirements and timelines. - Liaison with project requestors and to facilitate regulatory compliance and maintain integrity of drug product labeling. - Remain current on all regulatory, marketing, and industry developments. - Develop a working knowledge on evaluating regulatory risks prior to implementing regulatory strategies. - Provide regulatory support through the product life cycle. - Ensure routine reporting activities are accomplished efficiently and effectively. - Build long term effective relationships and open communication with Virbac France and all the Virbac subsidiaries in order to provide accurate information and timeframes. - Prepare budget, as needed, for the specific regulatory area. - Assist in other Regulatory activities as needed to assist the CReA team. - Provide technical support, advice and strategy to other teams within Virbac (e.g.

R&D, marketing, QA, Labeling team) for the A&P, DER, Drug listing, and labeling projects as applicable. Expected results: Develop and maintain regulatory procedures for the, A&P, DERs, Drug listings, and labeling projects to ensure consistent, efficient, timely, and compliant regulatory processes.

Area of accountability no.3: Knowledge Base Main activitie s: - Keep abreast of changes and proposed changes to regulatory requirements related to the drug product categories and processes. - Develop comprehension and application of the regulations and guidances for, A&P, DERs, drug listings,and labeling for the different product categories. - Support Marketing and Customer Experience teams to coordinate and complete the A&P reviews and submissions. - Support the PMO LPT to coordinate and complete the labeling projects in an efficient, timely and compliant manner. - Keep Management apprised of project obstacles, regulatory risks, or compliance concerns. - Update the Labeling Decision Team of labeling requirements and risks. - Complete regulatory assessments, as requested. - Monitor, interpret, and communicate regulatory requirements and risks to management and project teams, as applicable. - Participate in inter-departmental meetings to develop clear and realistic plans with milestones to achieve the desired outcomes, as applicable. - Collaborate with other departments to identify and understand areas for improvement and potential cost savings. - Expected results: Develop a knowledge base of the projects and the relevant requirements to meet regulatory agencies expectations and requirements, as applicable.

Support PMO LPT, Marketing, Communication Operations, and Pharmacovigilance departments to coordinate and complete accurate and timely reviews and updates of the projects. Keeps management and teams updated on the projects, as applicable to meet deadlines, address obstacles or compliance converns. Completes training as assigned and continues to look for opportunities for growth and development.

Virbac provides numerous career opportunities, thanks to the diversity of its jobs and their international dimension. Joining Virbac means joining dynamic teams ambitious for success. Add Your Talent to Ours!