Regulatory Specialist

Virbac•Westlake, TX

About The Position

Virbac Animal Health is seeking a Regulatory Affairs Specialist to maintain regulatory compliance and support timely, effective submissions to regulatory agencies. The role supports regulatory work for advertising and promotion (A&P), DERs, drug listings, and labeling projects, collaborating with internal teams, distributors, regulatory managers, and agencies. The specialist compiles and authors submissions, gathers supporting documentation, evaluates regulatory risks, researches applicable regulations and guidance, and coordinates submissions to meet requirements and project deadlines. The role also provides regulatory support throughout the product life cycle, helps maintain procedures, communicates regulatory requirements and risks, and develops effective working relationships across Virbac and with external stakeholders. A bachelor’s degree is required; a master’s degree and 1–3 years of regulatory experience are preferred.

Requirements

Bachelor’s degree required.

Nice To Haves

Master’s degree preferred.
1 to 3 years of previous experience in Regulatory preferred.

Responsibilities

Compile and author regulatory submissions for A&P, DERs, drug listings, and labeling projects, as applicable.
Evaluate regulatory risks and develop regulatory strategies.
Prepare, coordinate, and submit complete and accurate documents to regulatory agencies within project deadlines.
Collect and collate documentation needed to create submissions, and correspond with agencies as needed.
Coordinate with U.S. Regulatory Managers, distributors, requestors, and internal and external customers on project requirements and timelines.
Support Marketing and Communications with A&P reviews and submissions, and partner with Pharmacovigilance on DER updates.
Work with CMC Regulatory on drug listing updates and support the PMO Labeling Project Team on labeling evaluations and submissions.
Facilitate regulatory compliance and maintain the integrity of drug product labeling.
Remain current on regulatory, marketing, and industry developments; research and review regulations, guidance, and industry recommendations.
Provide regulatory support throughout the product life cycle and technical advice to teams such as R&D, Marketing, QA, and Labeling.
Develop and maintain regulatory procedures for A&P, DERs, drug listings, and labeling projects.
Complete routine reporting activities and prepare budgets for the regulatory area as needed.
Build effective working relationships and communication with Virbac France, subsidiaries, agencies, distributors, and internal teams.
Keep management and project teams apprised of obstacles, risks, compliance concerns, requirements, and timelines.
Update the Labeling Decision Team on labeling requirements and risks; complete regulatory assessments as requested.
Participate in interdepartmental meetings to establish plans and milestones, and collaborate to identify improvements and potential cost savings.
Complete assigned training and pursue opportunities for growth and development.