Job Description

职位名称 / Job Title

法规事务经理（Manager, Regulatory Affairs）

岗位使命 / Mission

以高质量、无延迟的申报与合规管理，确保新化药产品及时获批并合规上市。

Ensure timely approvals and compliant launches of new chemical entities through high-quality, no-delay submissions and compliance management.

主要职责 / Key Responsibilities

产品注册与维护：按中国法规提交/维护注册与变更资料，跟进审评，支持上市与供应链衔接。

Registration and maintenance: Prepare/maintain submissions per China regulations, track review progress, support launch and supply alignment.

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.

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：生物科学相关本科及以上；至少6年法规事务经验；熟悉中国兽药法规与审评实践。

Education & background: Bachelor’s degree or above in biosciences; 6+ years in regulatory affairs; familiarity with China veterinary drug regulations and review practices.

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.

Required Skills:

Adaptability, Audits Compliance, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Process Improvements, Project Management, Regulatory Affairs Management, Regulatory Compliance, Regulatory Operations, Regulatory Strategy Development, Regulatory Submissions

Preferred Skills:

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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:

Domestic

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:

05/22/2026

***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. **