Asso. Manager, Regulatory Affairs (Animal Health)

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. Additional location(s) Compensation Information: Required Skills: Drug Regulatory Affairs, Government Regulation, Influencing Skills, Influencing Without Authority, Policy Compliance, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails. 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 Job Posting End Date: 12/31/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.