Regulatory Affairs Specialist（药品法规事务（注册背景））

Responsible for regulatory affairs of API/Excipient, especially on excipient, provide regulatory support to Life science business. Include but not limited, Work with global team and/or local agency/site to prepare regulatory submission documents for API/Excipient products, implement API/Excipient products registration/supplementary applications. Manage the registration project progress, make sure to meet the timeline. Monitor Drug/API/Excipient related regulation changes, evaluate the impact, provide regulatory guidance in risk assessment and recommendations to mitigate potential risk. Work as effective interface between company and authority/industry association (IPEC, CDE, NIFDC, Jiangsu MPA, etc.).

MAIN JOB DUTIES/RESPONSIBILITIES

1. Coordinate with global regulatory counterpart to collect information required;

2. Carry out all necessary work to ensure the efficient and timely submission for API/Excipient products, including new registration/ supplementary application/deficiency letter response/registration testing, etc. to CDE and update in Merck’s system (Vault RIM) etc.

3. Certificate application/maintenance/notarization and legalization: API Written Confirmation Certificate application, Food additive manufacture license and drug manufacture license maintenance, etc. Certificate notarization and legalization for export/import case.

4. Support local business on daily basis request.

5. Monitor regulation development and participants in local association activity if necessary.

6. May support on other regulatory projects such as ChP project/IVD registration project etc.

EDUCATION AND LANGUAGE

1. Major in Biological, Microbiological, Pharmaceutical or related academic background with bachelor’s degree or above.

2.Chinese native & fluent English (verbal and written) are required.

PROFESSIONAL SKILLS AND EXPERIENCE:

1. Experience of minimum 1-2 years in registration or regulatory affairs in pharmaceutical, biopharma or related Industry.

2. Good regulatory knowledge of China laws and regulations in pharmaceutical including API/Excipient. Familiar with US and European regulations is preferred.

Experience in API & Excipient registration area is preferred.

PERSONAL SKILLS AND COMPETENCIES:

1. Ability to collaborate, management stress, and take initiative;

2. A positive, can-do attitude;

3. Good communication across multi-departments in multi- national cultures;

4. Strong organizational, time management and project management skills.

5. Ability to manage multiple priorities and deliver accurate outcomes.

工作地点：上海
岗位核心目的

负责原料药（API）/ 药用辅料注册事务，重点为辅料注册；为企业生命科学业务提供注册支持。主要包括：与全球团队及本地机构协作，准备原料药 / 辅料产品注册申报资料；执行原料药 / 辅料产品注册 / 补充申请；管理注册项目进度，确保按时交付；跟踪药品 / 原料药 / 辅料相关法规更新，评估影响，为风险评估提供合规指导并给出降险建议；作为公司与监管机构 / 行业协会（IPEC、CDE、中检院、江苏省药监局等）的有效对接窗口。

主要工作职责

1.与全球注册同事协作，收集所需信息；

2.开展原料药 / 辅料产品申报全流程工作，确保高效、按时向CDE提交新注册 / 补充申请 / 补正回复 / 注册检验等资料，并在默克系统（Vault RIM）中同步更新；

3.证书办理 / 维护 / 公证认证：办理原料药书面确认函、维护食品添加剂生产许可证及药品生产许可证等；进出口相关证书的公证与认证；

4.为本地业务提供日常注册支持；

5.跟踪法规动态，必要时参与本地行业协会活动；

6.可支持其他注册项目，如中国药典（ChP）项目、体外诊断试剂（IVD）注册项目等。

7.教育背景与语言要求

8.本科及以上学历，生物、微生物、药学等相关专业；

9.母语为中文，英语听说读写流利。

专业技能与经验要求

1. 1-2 年及以上制药、生物制药或相关行业注册 / 法规事务经验；

2. 熟悉中国药品相关法规（含原料药 / 辅料）；熟悉欧美法规优先；

3. 有原料药及辅料注册经验优先。

个人能力与素质要求

1.具备协作能力、抗压能力及主动性；

2.积极主动、执行力强；

3.擅长跨部门、跨文化沟通；

4.优秀的统筹、时间管理与项目管理能力；

5.能同时处理多项工作、输出精准结果。