CMC Expert China-NBE-235530
Talent@Boehringer Ingelheim https://www.boehringer-ingelheim.cn/
About Human Pharmaceutical Business
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.
With global presence, Boehringer Ingelheim has industry-leading expertise in medicine research and development. We are constantly developing the next generation of medical breakthroughs and successfully delivering innovations to meet the medical needs of the patients we serve in the following key areas of interest: cardiovascular, respiratory, metabolic diseases, immunology, oncology and central nervous system. In the future, the company will launch new medicines or indications in therapeutic areas including CV & metabolism, respiratory, oncology, immunology, CNS and retinal health to meet the demand of Chinese patients.
Job Responsibilities
Qualifications
- Provide technical supports to CMC dossier related activities (e.g., dossier review, proofreading, HA interactions and responses) for China CTA and NDA submissions
- Participate in LPT, TARM, and PEC as needed for China development project discussion and update
- Work closely with TCM Medicine relevant functions (e.g., LRA, PPM/RIL, Clin Ops, Clin Dev) in ensuring the timely and quality submissions
- Fully understand the plan, progress, and status of the pipeline development projects in China and reflect the information properly to global CMC Experts NBE and relevant functions
- Work with global CMC Experts NBE in providing necessary support during dossier preparation (e.g., consultation, drafting, review), esp. for China specific documents
- Support RA/CMC RA in preparation of submissions in China and in meetings with the authorities by providing scientific input and support in personal and through the relevant experts in the global Development network
- Contribute to interactions with Chinese regulatory agencies and institutions (e.g. NMPA/CDE/NIFDC/Chinese Pharmacopeia/RDPAC), based on proactive work with BI-China functions (primarily LRA), Global Development functions and industry consortia
- Provide technical input or leverage expertise within Global NBE Development related to CMC topics specific to China
- Monitor, translate, and communicate strategic changes related to CMC development in China to key stakeholders in Global NBE CMC Experts
Qualifications
- Ph.D. degree with more than 5 years or master’s degree with 8 years of professional experience in pharmaceutical industry
- Broad experience in NBE drug development, having expertise in analytical, bioprocess and pharmaceutical development, expertise in combination product development is a plus
- Experiences in CMC dossier preparation, submission, regulatory science and Health Authority interactions with Chinese HAs
- Familiar with CMC technical aspects of the China submission process and requirements for new drugs
- Good understanding of ICH regulations is a plus
- High learning agility
- Entrepreneurial thinking and attitude
- Strong interpersonal & communication skills
- Fluent in both Chinese and English
- Excellent planning and organizational skills
- Willingness to travel on a regular basis (ING/BC, US, China)
工作 - 研发
主要地点 - Africa, Asia, Australasia-CN-上海-上海
组织 - 勃林格殷格翰（中国）投资有限公司
编制 - 全职
