Regulatory Affairs Senior 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.

This position will have a focus on promotional materials (A&P), Drug Experience Reports (DERs), Drug listings for Virbac application drug product categories, and labeling project reviews.
Within the framework of Virbac U.S. strategy, the Associate Manager is responsible for ensuring regulatory compliance with relevant regulations and effectively sending timely submissions to the appropriate regulatory agencies. The Associate Manager will also work with Project Management Operations (PMO) to assist in coordinating labeling project reviews, with Marketing and Communications to coordinate A&P reviews, with Pharmacovigilance to coordinate the DERs, with CMC Regulatory for Drug listings for the drug listing updates.
Area of accountability no.1: Regulatory Submissions
Main activities:
-Compile and author submissions to meet regulatory requirements for the labeling projects, A&P, DERs, and Druglistings, as applicable.
-Evaluate risks prior to implementing regulatory strategies.
-Ensure the preparation of drug labeling projects, A&P, DERs, and Drug listings are processed and submitted to theagency, 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 labeling projects, A&P reviews, DERs, Drug listingsand submissions.
-Liaison with the Distributors as needed for labeling projects, A&P reviews, DERs, Drug listings and submissions, asapplicable.
-Research and review the regulations, guidances, and industry group recommendations, as applicable, in order todevelop into the Regulatory Associate Manager role.
Expected results: Continue to develop comprehension and application of the regulations and guidances for the labeling, A&P, DERs, and Drugs listings of the drug product categories. Review, coordinate, and provide feedback on the labeling projects, A&P, DERs, and Drugs listings, 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 project requestors and to facilitate regulatory compliance and maintain integrity of drug productlabeling.
-Liaison with the U.S. Regulatory Managers, Distributors, and other external and internal customers to meet thelabeling project, A&P, DER, and Drug listing requirements and timelines.
-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 inorder 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, Labelingteam) for the labeling projects, A&P, DER, and Drug listing, as applicable.
Expected results: Develop and maintain regulatory procedures for the labeling projects, A&P, DERs, and Drug listings to ensure consistent, efficient, timely, and compliant regulatory processes.

Area of accountability no.3: Knowledge Base
Main activities:
-Keep abreast of changes and proposed changes to regulatory requirements related to the drug product categoriesand processes.
-Develop comprehension and application of the regulations and guidances for labeling, A&P, DERs, and drug listingsfor the different product categories.
-Support the PMO department to coordinate and complete the labeling projects in an efficient, timely and compliantmanner.
-Support Marketing and Communications departments to coordinate and complete the A&P reviews and submissions.
-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, asapplicable.
-Participate in inter-departmental meetings to develop clear and realistic plans with milestones to achieve thedesired outcomes, as applicable.
-Collaborate with other departments to identify and understand areas for improvement and potential cost savings.
Expected results: Continue to develop a knowledge base of the projects and the relevant requirements to meet regulatory agencies expectations and requirements, as applicable. Support PMO, 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. Completes training as assigned and continues to look for opportunities for growth and development.

Training / Experience necessary to fulfill the job: job-related skills required to complete activities
1.Educational level or equivalent experience: Bachelor's degree, preferred.
2. Total number of years' experience required to fulfill the role: 2-5 years.
3.Career pre-requisites: Position requires an initial knowledge of and ability to interpret, understand and communicate regulations and regulatory language with preference of previous direct interaction with US regulatory agencies (FDA. EPA, USDA). Position requires approximately 5% travel.

Behaviour: interpersonal skills required to complete activities

1.Analyze problems and situations
2.Make sound and courageous decisions
3.Demonstrate drive and results orientation
4.Demonstrate the ability to anticipate and plan
5.Demonstrate team work and develop cross-functional collaboration
6.Influence or persuade others to get ideas accepted

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

---