Global RA (Pharmaceuticals)

Job Summary:

1. 该职位制定全球注册策略,主导国际申报全流程,驱动客户公司药品全球化上市进程。

This role develop global regulatory strategies and lead the entire international submission process to accelerate the global launch of sponsor's pharmaceutical products.

2. 该职位深耕FDA/EMA法规体系,为客户提供高效、合规的一站式注册解决方案。

Deep understanding of FDA/EMA regulatory frameworks, to deliver efficient and compliant one-stop registration solutions for clients.

Job Responsibilities:

1. 负责/统筹药品注册申报资料(药学、药理毒理、临床等模块)的撰写、形式审核、技术审核及最终整理。

Lead and oversee the writing, review, and compilation of regulatory submission dossiers (covering CMC,

Pharmacology/Toxicology, and Clinical sections).

2. 确保申报资料的科学性、逻辑性和完整性,完全符合中国NMPA、美国FDA、欧盟EMA等全球主要监管机构的法规要求。

Ensure the scientific soundness, logical coherence, and completeness of dossiers, ensuring full compliance with regulatory

requirements of major health authorities such as China NMPA, US FDA, and EU EMA.

3. 根据产品特性及目标市场,负责制定并优化全球药品注册策略,包括但不限于美国FDA(505b2/ANDA)、欧盟EMA(DCP/互认程序M

RP/集中程序CP)的注册路径规划。

Develop and optimize global regulatory strategies based on product characteristics and target markets, including

submission pathways for US FDA (e.g., 505(b)(2), ANDA) and EU EMA (DCP, MRP, CP).

4. 为客户提供关于产品开发中的法规可行性建议,最大限度地缩短注册周期。

Provide clients with strategic regulatory advice during product development to minimize time to approval.

5. 组织并协调eCTD(电子通用技术文档)格式药品注册资料的编制、生命周期维护及电子提交。

Organize and coordinate the compilation, lifecycle maintenance, and electronic publishing of eCTD-compliant regulatory

submissions.

6.负责创新药临床试验申请(IND)、新药上市申请(NDA/ANDA)及上市后维护(MAH)等注册项目的全生命周期跟进,确保项目里程

碑按时达成。

Manage the end-to-end tracking of regulatory projects, including IND, NDA/ANDA, and post-approval variations (MAH),

ensuring all project milestones are met.

7. 持续跟踪和解读海内外最新的药品注册法规、技术指南及ICH(人用药品技术要求国际协调理事会)指导原则。

Continuously monitor and interpret the latest global regulations, guidelines, and ICH harmonized tripartite guidelines.

8. 支持上级分配的其它工作内容。

Support other tasks assigned by superior.

Qualifications

1)药学、化学、生物学、医学或相关专业本科及以上学历。

Bachelor's degree or higher in Pharmacy, Medicine, Chemistry, Biotechnology, or a related life science field.

2)5年以上药品注册相关工作经验,其中至少2年以上直接负责海外注册(FDA/EMA)的经验。

Minimum 5 years of experience in pharmaceutical regulatory affairs, with at least 2 years of direct experience in international submissions (FDA/EMA).

3)具有CRO(合同研究组织)、跨国药企或大型制药企业注册部门工作经验者优先。

Previous experience in a CRO (Contract Research Organization), multinational pharmaceutical company, or a large local pharmaceutical company's regulatory department is highly preferred.