(Sr.) Regulatory Affairs Supervisor 注册事务主管
主要职责:

岗位职责:

Responsibilities:

1. 协助直线上级完成产品的相关模块资料的准备,撰写、校对产品注册所需的资料(包括但不限于CMC、毒理药理实验、临床试验等模块资料),跟进注册进度和检查,回复审查意见,及时协调解决注册过程中出现的问题;
Assist line manage to prepare, generate and review the dossiers (include but not limited to CMC & Non-clinical & Clinical module) of Company’s products’ IND/NDA submission package; keep tracking the product registration process, response of evaluation comments from authority; handle the review issues timely with colleagues;
2. 协助直线上级完成公司产品线各产品全生命周期的注册申报工作;
Assist line manage to execute the All life -cycle regulation affairs management of Company’s products;
3. 跟进国内外各项药事法规、指导原则、技术文件等的最新动态,为产品技术资料撰写提供法规政策保障。

Search and follow up and the regulations & guideline & tech documents which from domestic and overseas, provide policy support for company products’ submission dossiers.

       

任职要求:

任职要求:

Qualifications:

1. 要求生物学或药学背景,本科及以上;

Bachelor Degree or above in bioscience or related field required;

2. 具有3-5年医药行业注册工作经验,有生物药品IND、NDA和补充申请相关技术资料撰写经验者优先;

3-5 years of experience in pharmaceutical industry, successful IND &NDA& supplement application experience prefer;

3. 了解CFDA、FDA、ICH等法规体系,对药政相关法规敏感度高;

Understanding the regulation system of CFDA & FDA & ICH, familiar with CFDA relevant regulations, standards and guidance, follow up the changes to the regulatory environment;

4. 了解或熟悉CTD格式/eCTD申报资料系统者优先;

Understanding and familiar with the requirements and processes of CTD/eCTD prefer;

5. 良好的沟通能力,有一定的英文口语和写作能力;

Excellent verbal and written communication skills, good knowledge of written and spoken English;

6. 工作积极主动,有责任心,勇于承担,亲和力和沟通协调能力强;

Ability to handle multi-task activities, ability to handle conflict; initiative and negotiation skills.

招聘人数:1