Asso. Manager, Regulatory Affairs (Animal Health)

Job Title

法规事务助理经理（Associate Manager, Regulatory Affairs）

Mission

通过高质量、高效率的产品生命周期管理与合规运营，确保已上市兽用疫苗产品持续合规、稳定供应。

Ensure the ongoing compliance and reliable supply of marketed veterinary vaccines through high-quality lifecycle management and regulatory compliance.

Key Responsibilities

• 产品注册与生命周期管理：依据中国法规要求完成注册、续展、变更等申报工作，跟进审评进展，保障产品持续合规和稳定供应。Registration and lifecycle management: Prepare and maintain regulatory submissions, including registrations, renewals, and variations, in accordance with China regulations; track review progress and ensure ongoing compliance and reliable product supply.
• 法规指导：为研发与商业化提供清晰、及时、可落地的法规建议与路径。Regulatory guidance: Provide clear, timely, actionable regulatory advice for R&D and commercialization.
• 法规与标准管理：跟踪并评估法规、兽药典标准及技术指导原则变化，推动内部实施，确保产品持续符合监管要求。Regulatory and standards management: Monitor and assess changes in regulations, pharmacopoeia standards, and technical guidelines; drive internal implementation and ensure continued compliance with regulatory requirements.
• 合规管理：监测法规变化，维护产品全生命周期合规，推动必要的内部改进。Compliance oversight: Monitor regulatory changes, ensure lifecycle compliance, drive essential internal improvements.

Requirements

• 学历与背景：预防兽医、生物科学或相关专业本科及以上学历；至少6年法规事务经验；熟悉中国兽药法规、审评实践、法规标准体系及技术指导原则，具备相关要求解读与实施经验。Education & background: Bachelor’s degree or above in Preventive Veterinary Medicine, Biosciences, or a related field; 6+ years of regulatory affairs experience; strong knowledge of China veterinary drug regulations, review practices, regulatory standards, and technical guidelines, with demonstrated experience in their interpretation and implementation.
• 关键能力（对齐岗位意义：及时拿证/解决问题）/ Core capabilities (aligned with role purpose: timely approvals/problem-solving):清晰度：能清晰定义问题与路径，提供明确法规指导，确保沟通高效、信息无歧义。Clarity: Ability to define issues and pathways clearly, provide precise regulatory guidance, and communicate without ambiguity.及时交付：时间敏感与按期交付，首次准确（First-time-right），在压力下保持质量与速度。No delay: Time sensitivity and on-time delivery, first-time-right quality, maintaining speed and quality under pressure.关键问题处理：快速识别关键点，完成结构化分析并提出可执行建议，推动闭环解决与经验沉淀。Critical issue handling: rapid identification, structured analysis and actionable recommendations, and driving closure with learnings captured.风险判断与承担：准确解读法规与监管期望，评估选项与边界，适时升级并高质量落地。Risk judgment and ownership: accurate interpretation of regulations, assessment of options and boundaries, timely escalation, high-quality execution.战略思维：在商业与技术框架下做出务实选择，平衡资源与合规风险。Strategic thinking (1-year horizon): Pragmatic choices within business and technical frames, balancing resources and compliance risk.团队协作与影响：稳定交付，支持团队成员，跨部门协同提升整体效率；具备职权或非职权领导力与谈判影响力。Collaboration and influence: Reliable delivery, support teammates, cross-functional coordination to lift efficiency; authority or informal leadership and negotiation influence.

Foundational skills and attributes

• 优秀的沟通与组织能力；强逻辑与数据分析能力；细节导向与质量意识。Excellent communication and organization; strong logic and data analysis; detail orientation and quality mindset.
• 熟悉新产品开发流程与质量管理体系；具备日常法规决策与假设管理能力。Familiarity with new product development processes and QMS; capable of day-to-day regulatory decision-making and hypothesis management.
• 自我驱动、有担当，能在最少监督下高效工作。Self-driven with ownership; effective under minimal supervision.

Required Skills

• Drug Regulatory Affairs
• Government Regulation
• Influencing Skills
• Influencing Without Authority
• Policy Compliance
• Regulatory Affairs Management
• Regulatory Compliance
• Regulatory Operations

Employee Status

Regular

Relocation

No relocation

VISA Sponsorship

No

Travel Requirements

10%

Flexible Work Arrangements

Not Applicable

Shift

Not Indicated

Valid Driving License

No

Hazardous Material(s)

n/a

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