CMC Expert I/II Full-time Job

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

Our Company

Why Boehringer Ingelheim?

With us, you can develop your own path in a company with a culture that knows our differences are our strengths - and break new ground in the drive to make millions of lives better.

Here, your development is our priority. Supporting you to build a career as part of a workplace that is independent, authentic and bold, while tackling challenging work in a respectful and friendly environment where everyone is valued and welcomed.

Alongside, you have access to programs and groups that ensure your health and wellbeing are looked after - as we make major investments to drive global accessibility to healthcare. By being part of a team that is constantly innovating, you'll be helping to transform lives for generations.

Want to learn more? Visit https://www.boehringer-ingelheim.com