Associate Regulatory Affairs Manager

About Animal Health Business

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:

1. Regulatory Strategy and Project Leadership
- Lead regulatory projects for biological products, covering development, registration, manufacturing-related approvals and other assigned activities.
- Develop and implement China regulatory strategies aligned with product plans, business objectives and applicable requirements.
- Define regulatory pathways, submission strategies, key milestones and deliverables, and independently lead execution across local and global functions.
- Assess development plans and registration packages, identify China-specific gaps and recommend practical solutions.
- Lead regulatory submissions and authority interactions, ensuring that submissions and responses are complete, scientifically justified and compliant.
- Take accountability for obtaining the required regulatory approvals and proactively manage significant regulatory risks.

2. Product Lifecycle Management and Regulatory Compliance
- Lead regulatory maintenance activities for assigned biological products, including variations, renewals, manufacturing changes and other post-approval requirements.
- Assess the regulatory impact of proposed product, manufacturing, quality, labeling, packaging, supply or commercial changes.
- Define and coordinate the required regulatory actions to maintain product registrations and support continued manufacturing, marketing and supply.
- Ensure that regulatory commitments, approval conditions, product information and documentation remain compliant and current.
- Identify and address compliance, registration and supply continuity risks, and escalate material risks with recommended mitigation measures.

3. Regulatory Intelligence and External Engagement
- Maintain advanced knowledge of Chinese regulations and authority practices relevant to biological products.
- Assess regulatory developments and provide practical recommendations to relevant stakeholders.
- Build effective relationships with regulatory authorities, technical institutions and external experts.
- Represent the company in external regulatory interactions and translate feedback into project actions.

4. Regulatory Operations，Professional Guidance and internal communication
- Maintain accurate, complete and traceable regulatory records, databases and project information.
- Provide timely regulatory project and portfolio updates.
- Identify process gaps and implement improvements to regulatory processes and tools.
- Provide expert review, technical guidance and knowledge sharing within the assigned regulatory scope.
- Facilitate smooth communication with local and global stakeholders to support project execution and team operation.

Job Requirement:

-At least master degree in veterinary medicine or life science

-At least 8 years working experience in Regulatory Affairs or other relevant functions within veterinary or life science industry. Experience in multinational companies is preferred. 
-Solid experience in biological product registration, dossier preparation, lifecycle management, or change-related regulatory activities. Experience in site transfer, manufacturing change, technical variation, or related regulatory support is preferred.
-Solid understanding of registration requirements, dossier support, and lifecycle management for pharmaceutical products. Experience in Hong Kong registration is an advantage.
-Strong communication, project coordination, stakeholder management, and problem-solving skills.
-Able to work independently, manage priorities, and provide practical regulatory guidance in a dynamic environment.
-Good written and spoken English and Chinese.