Regulatory Specialist

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.

Area of Accountability 1: Regulatory Submissions

• 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.

Area of Accountability 2: Quality Control

• 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.

Area of Accountability 3: Knowledge Base

• 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.