GMP & Regulatory Affairs Engineer | GMP与法规工程师
About the role
Description
JOB TITLE / 职务名称: Good Manufacturing Practices and Regulatory Affairs Engineeer
DEPARTMENT / 部门: QUALITY
DATE / 日期: 2026-07-08
BASIC PURPOSE OF THE JOB / 设立该职务的基本目的
As the contact window with authority, He/She will be in charge of the compliancy of the factory with the regulation (RA) and good manufacturing practices (GMP).
POSITION WITHIN THE ORGANIZATION / 该职务在组织中的位置
JOB TITLE OF THE SUPERVISOR / 上级的职务: Quality Assurance (QA) Assistant Manager
JOB BEING DESCRIBED / 本职位名称: Good Manufacturing Practices and Regulatory Affairs Engineeer
JOB TITLE OF SUBORDINATES / 下属的职务: NA
KEY COMPETENCIES FOR THE POSITION/ 该职务所需的主要资质
- Bachelor’s degree or above (Pharmacy, Medical, Chemical, Food, Cosmetics)
- 1-2 years' experience in a role of cosmetics registration or Cosmetics plant working experiences.
- Familiar with Chinese Cosmetic registration regulations, with an excellent acquaintance about GMP requirements for a cosmetic factory operated under the supervision of NMPA.
- Demonstrated ability to guarantee the conformity of the site and its documents to the regulation.
- Excellent communications skills (oral and writing); with internal stakeholders and authorities.
- Fluent Chinese and English speaking and writing (CET-6). French is a plus.
CONTACTS AND RELATIONS/ 与该职务有联系或相关的人或组织
Internal / 内部的:
· Quality: Quality Assurance, Quality Control, Laboratories
· Import and Export
· Engineering: Technical Team, Industrialization team, Facility, EHS
· Central Regulatory teams (in Shanghai and France)
External / 外部的:
· Shanghai authorities (NMPA and local subsidiaries)
· Third-party (in charge of audits, trainings, etc)
DETAIL RESPONSABILITIES / 主要职责
Products notification
- On-line notification for the products (exported products);
- Exportation files for CIQ team;
- Government system maintenance including but not limited to notification, registration, renewal, modification, cancellation, etc
Manufacturing License Management
- Lead the organization, preparation and follow-up of audits (internal, external) with CAPA
- Layout and process modification, Quality responsible person modification and other modification related.
- Government system maintenance (license system)
Good Manufacturing Practice
- Maintain quality system documents
- Deal with GMP related deviation
- Handle yearly GMP training
- Supervise yearly activities (training schedule, internal GMP audit)
Internal Compliance & Regulatory Support
- Gap analysis
- Regulation sharing: Review, interpret changed legislation; identify and keep track of upcoming changes in the regulatory environment and emerging issues.
- Contact window with authorities and other third-party
- Propose ways to maintain relationship with authorities
- Deliver explanation of the regulation
Other assignments given by manager
MAIN KPIs OF THIS POSITION / 该职务的主要业绩指标
- Finish on-line notification right first time, and on-time: 100%
- Complete CIQ exportation files right-first-time and on-time: 100%
- Audit pass rate: 100%