Job Description

主要职责：

负责新产品的注册、进口及国产批准，确保产品的合规性。为新产品开发和中国市场运营提供明确、及时且实用的法规指导，有效解决问题。​

工作内容包括但不限于：

产品注册与维护 – 翻译、审核、整理并提交新产品的注册材料，以及已有产品的变更注册资料。在既定时间内，根据中国法规和指南完成注册，确保产品的合规性，并协助推动产品上市及供应链管理。重点关注关键问题的识别与解决，尽力提高工作效率。​

所需技能包括但不限于：

具有相关生物科学的本科或研究生学位。至少5年的法规事务工作经验，熟悉中国兽药法规。 优秀的沟通和组织技能，较强的谈判和影响力，关注细节。 熟练进行风险分析与管控。熟知公司新产品开发流程。熟悉质量管理体系。 数据分析能力强，有逻辑地分析问题并提出解决方案。具备假设管理能力。 善于在团队环境中与其他部门积极合作。 自我驱动，能够积极独立工作。 能在压力下工作，按时完成任务。 能在日常法规事务中做出合理决策。具备职权或非职权领导力。​

衡量标准：​

关键问题 - 可辨别关键问题、对问题做出深度分析、提出具体解决建议、领导70%以上问题的解决、总结经验教训、推动部门内流程改进、组织协调跨部门沟通、深度理解法规并灵活应用到关键问题的识别与解决中。​风险承担 - 认法规清灰色地带，提出解决问题的风险方案，评估风险大小，判断是否交给经理决定，之后负责实施。​战略思维 - 熟练地从公司商业模式的广度、科技底层逻辑的深度、前瞻未来1-5年的时间长度思考关键问题， 并制订计划。​领导力 -带领团队，在团队中承担无职权领导责任，带领项目团队完成目标。激励项目团队成员，提供指导和支持，确保团队合作融洽。​

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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Applicable

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Adaptability, Adaptability, Audits Compliance, Biological Sciences, Business, Communication, Data Analysis, Detail-Oriented, Drug Regulatory Affairs, Employee Training Programs, Global Communications, Leadership, Management Process, Negotiation, Pharmaceutical Regulatory Affairs, Pharmacovigilance, Problem Solving, Process Improvements, Product Development, Project Management, Quality Management, Quantitative Abilities, Regulatory Affairs Compliance, Regulatory Affairs Management, Regulatory Compliance {+ 5 more}

 Preferred Skills:

Job Posting End Date:

09/30/2025

*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.

Requisition ID:R355889