Manager, International Regulatory Affairs

Company: Virbac
Location: Bridgeton
Posted on: May 26, 2023

Job Description:

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.

Responsibilities

Area of responsibility 1: Coordination of Postapproval Change Assessments

Acts as the US regulatory contact for global affiliates responsible for evaluation of the regulatory impact of CMC and labeling changes for US-manufactured products distributed outside the US:

• Communicates to the affected affiliates the objectives of the change, the planned project steps, critical path, and associated risks, and the business, industrial, compliance, maintenance, and packaging impacts
• Using the regulatory assessments from each of the affected affiliates, prepares a macro schedule for implementing the change with target dates for obtaining approval from the relevant Regulatory Authorities
• Summarizes the global regulatory analysis for communication to the US site team Throughout the duration of the project, communicates with the affected affiliates progress regarding:
  • The availability of documentation needed for regulatory filings
  • Any problems or issues arising, including the proposed action plan to resolve them
  • The US regulatory assessment, submission, and approval of the change At the end of the project:
    • Ensures the relay of regulatory approval information from the affiliates to the US site team
    • Informs the affiliates of change implementation dates Expected results: Ensures affiliates understand the necessary details of postapproval changes; the operational plan is implemented within the defined timelines
      
      Area of responsibility 2: Support for Global Affiliates
      
      Supports the affiliate regulatory teams in the overall management of their regulatory actions:
      • Maintains an overview of all US variation projects in progress with each affiliate and understands their available bandwidth
      • Assists affiliates with action planning by identifying priority actions, taking into account the affiliate's other regulatory project responsibilities
      • Collaborates with affiliates on a tool to manage regulatory activities for US variation projects
      • Organizes follow-up meetings in order to assess the overall regulatory burden of the affiliates (new filings and life-cycle management) and its evolution during the year Expected results:Ensures alignment between Virbac US and the global affiliates on LCM regulatory priorities, taking into account available resources
        
        Area of responsibility 3: Analysis of Major Variation Projects
        
        Main activities
        • Through information exchange with affiliates, evaluates the feasibility of major variation projects with the available data or determines the additional regulatory and technical information required for regulatory filings
        • Communicates any shortcomings or discrepancies in the scientific parts of the file to subject matter experts (SMEs) and collaborates with SMEs to identify problem-solving options
        • With the support of local teams, defines a schedule for the delivery of US documentation to the affiliates and for filings with the relevant Regulatory Authorities
        • Identifies opportunities to improve internal processes to gain reliability and efficiency Expected results: Ensures relevant analysis of major variation projects in order to ensure feasibility and anticipate difficulties
          
          Area of responsibility 4: Regulatory Tools
          
          Main activities
          • Enters key dates for major variation projects in a regulatory database and project management tool
          • Updates estimated end of action dates for ex-US regulatory filings in the regulatory database
          • Verifies the accuracy and quality of ex-US regulatory information entered into the internal change control system
          • Contributes to regulatory traceability by maintaining a repository of all regulatory documents exchanged with the ex-US authorities as part of each project
            
            Expected results: Ensures the accuracy and quality of regulatory information entered into the change control system
            
            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!

Keywords: Virbac, Springfield , Manager, International Regulatory Affairs, Executive , Bridgeton, Illinois