GMP & Regulatory Affairs Engineer | GMP与法规工程师

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%