CMC Expert

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, we will accelerate the launch of more than 10 innovative medicines to meet the demand of Chinese patients.Job

Responsibilities

• Participate in local project relevant teams and meetings as needed for China development project discussion and update

• Work closely with T.C.M. Medicine relevant functions (e.g., LRA, TAs, Clinical Dev & Ops) 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 primarily and relevant functions

• Work with global CMC Experts NBE primarily in providing necessary support during dossier preparation (e.g., consultation, drafting, review), esp. for China specific documents

• 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 primarily

• Provide technical supports (as above) to NCE projects as needed and assigned

• 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 network

•Contribute to interactions with Chinese regulatory agencies and institutions (e.g. NMPA/CDE/NIFDC/Chinese Pharmacopeia/RDPAC) as needed, by working with relevant China functions and global functions

• Contribute to other activities and events of the department and/ or Company

Job Requirements

• Ph.D. degree with more than 3 years or master’s degree with 6 years of professional experience in pharmaceutical industry

• Broad experience in NBE drug development, having expertise in analytical, bioprocess and pharmaceutical development, experience in NCE drug 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 (ING/BC, US, China) as needed