Job Description:

职位名称 / Job Title

法规事务专员（Executive, 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3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; 3 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.

加分项 / Nice-to-have:

加速获批或复杂项目注册经验；流程优化或知识管理经验。

Experience in accelerated approvals or complex registrations; process optimization or knowledge management experience.

Required Skills:

Accountability, Adaptability, Detail-Oriented, Documentations, Electronic Common Technical Document (eCTD), Employee Training Programs, Mentorship, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Technical Writing

Preferred Skills:

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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:

No Travel Required:

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

03/31/2026

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.