Regulatory Affairs & PV Manager
About Animal Health in China
As the leading animal health company in China, we have extensive business coverage from the full value chain in R&D, production to sales and a diversified product portfolio covering swine, poultry, pets, cattle vaccines and medicines. We are always "in China and for China". We've pioneered many game-changers in the veterinary medicine, and we're looking to our customers' needs to guide us into the future.
Job Responsibility:
-Regulatory Strategy and Project Leadership: Act as the Regulatory Affairs representative and regulatory project lead for assigned development and lifecycle projects.
-Submission and Regulatory Delivery: Determine regulatory data and documentation requirements for assigned projects based on product characteristics, development stage and applicable regulations.
-Regulatory Intelligence and Advisory: Maintain current knowledge of relevant laws, regulations, guidelines, standards and regulatory practices affecting biological products.
-Networking and Stakeholder Engagement: Build and maintain trusted working relationships with relevant authorities, industry bodies, academic institutions, external experts and other professional stakeholders, in line with company policies.
-Operational Excellence and Compliance: Ensure regulatory activities and documentation comply with applicable regulations, internal policies, SOPs and quality standards.
-Collaboration and Functional Contribution: Partner effectively with R&D, Quality, Manufacturing, Clinical, Commercial, Legal and other relevant functions.
Job Requirements:
-Master's degree or above in veterinary medicine, biology, biotechnology, pharmacy or another relevant life-science discipline. An advanced degree may be an advantage.
-Minimum 5-8 years relevant experience in Animal Health Regulatory Affairs
-Experience leading or coordinating cross-functional projects in a regulated environment.
-Experience in an international or matrix organization is preferred.
-Strategic and analytical thinking, with sound judgment and practical problem-solving skills.
-Project leadership, planning, prioritization, and delivery discipline.
-Ability to interpret scientific and regulatory information and communicate implications clearly.
-Strong stakeholder management, influencing, negotiation and networking skills.
-Fluent written and verbal communication in Chinese and English; ability to work effectively across cultures and functions.
-High integrity, learning agility, collaboration and accountability.
-Ability to work independently while proactively seeking alignment and escalating significant risks.