Lead and oversee regulatory activities for pre-approval and life cycle management
Collaborate with key stakeholders including Global R&D, Sales & Marketing, and Technical Services
Accountable for regulatory strategy in all key first-wave countries
Manage and prioritize resources to meet project timelines and objectives
Engage with regulatory agencies in the EU/USA and develop relationships with global regulatory authorities
Represent the regulatory viewpoint on development and governance teams
Initiate the generation and review of policies, SOPs, and guidance to ensure compliance
Lead team meetings regarding Quality, Safety, and Effectiveness technical sections during regulatory agency interactions

Master’s degree or higher in Veterinary Medicine, Biology, Infectious Diseases, Immunology, or a related field
At least 10 years of relevant animal health industry experience
Direct Regulatory Affairs expertise with Pharmaceutical, Biological, and/or Nutritional products
Comprehensive understanding of global regulatory procedures for veterinary medicinal products
Strong grasp of risk assessment and risk management fundamentals/tools
Demonstrated effectiveness in business partnering across the enterprise, functions, and with external stakeholders
Ability to align resources with company objectives and facilitate accurate, timely project and budget forecasts
Demonstrated courage in navigating difficult situations.

Global Regulatory Project Lead – Global Regulatory Affairs

Key skills