北京 Associate Regulatory Affairs Manager 中国

Job description

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. 立即申请 » 查找类似职位: 数据隐私 © 2010-2023 Boehringer Ingelheim GmbH