Job Description

职位名称 / Job Title

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

岗位使命 / 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.

主要职责 / 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.

任职要求 / 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, 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, and 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.

基础技能与素质 / 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.

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