北京招聘

Company Introduction

Legend Biotech is an emerging company focusing on the development of the best-in-class immunotherapy technology for cancer cure. Teamed up with outstanding immunologists and molecular biologists, Legend has generated a strong pipeline of cell therapy product candidates to treat a wide variety of liquid and solid tumors. Legend Biotech is founded on the vision that the previous incurable previous incurable cancer will be safely and effectively treated with fine-tuning products generated on our innovative technology platform.

Location: Nanjing or Shanghai

Job Details:

Reporting to VP of Regulatory Affairs, the Director/Sr. Director of Regulatory Affairs is responsible for developing, coordinating and executing regulatory strategies in Greater China, guiding staff at all levels on appropriate regulatory strategies with respect to Nonclinical and Clinical aspects of the programs. The Director/Sr. Director will lead a team of regulatory associates to implement the agreed upon registration strategy.

Key Responsibilities:

• Responsible to proactively develop innovative, robust regulatory strategies in Greater China and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development in oncology, Immunology and Infectious diseases
• Ensure timely and high quality submissions
• Provide guidance and oversight for health authority interactions/meetings
• Provide input to global regulatory strategies for each project within the Therapeutic area(s)
• Direct the team efforts required for the submission of INDs, BLAs, sBLAs as well as related supplements and annual reports.
• Represent the RA department on internal cross-functional teams for activities such as SOP development, business process improvements, etc.
• Regulatory representative on due diligence activities for external development candidates
• Coach and mentor junior members in their roles on global project teams and as the leader of regional regulatory team
• Have an understanding of the competitive environment of the various indications in oncology, Immunology and Infectious diseases
• Provides regular and timely updates to senior management on the status of all pending applications and planned submissions as necessary

Qualifications & Skills:

• Minimum M.S. degree in life/health sciences required
• A minimum of 10+ years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Authorization Applications
• In depth knowledge of China regulatory guidelines and knowledge of global regulatory requirements
• Ability to work independently within project teams, committees, etc. to attain group goals
• Demonstrate excellent communication skills
• Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload
• Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff
• Experience in interfacing with relevant regulatory authorities.
• Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements
• Fluent in English

金斯瑞生物科技股份有限公司（股票代码HK01548）是全球化的生物科技集团公司。集团植根于领先的基因合成技术，核心业务范围已涵盖生物药开发与生产CDMO业务、细胞与基因治疗、生命科学服务及产品、生物酶及合成生物学产品四大领域。

金斯瑞成立于2002年，并于2015年在港交所主板挂牌上市。集团总部位于中国南京，运营实体遍布大中华区、北美区、欧洲区及亚太区，并以此为依托，为全球160多个国家和地区的10多万客户提供优质、便捷、可靠的服务与产品。

目前，金斯瑞在全球拥有超过3000名员工，其中34%以上的员工拥有硕士或博士学位。金斯瑞拥有多项知识产权及技术机密，其中包含100多项授权专利及270多项专利申请。截至2019年6月30日，有超过40,300篇经国际同业审阅的学术期刊文献引述了金斯瑞的服务及产品。

秉承“用生物技术使人和自然更健康”的企业使命，金斯瑞将一如既往地致力于成为最受信赖的生物科技公司。