Senior Specialist/Associate Manager, RA
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.
Responsibilities
- Contribute China CMC regulatory strategy and manage regulatory CMC risks across development and lifecycle stages
- Review China specific CMC dossiers ensuring compliance with China regulatory requirements
- Support CMC responses to authority questions and deficiency letters
- Support with China Health Authorities (e.g. IDC) and support regulatory interactions such as on method handover and QC testing
- Partner with global and cross-functional teams to deliver general China regulatory CMC position from country level
- Maintain internal regulatory CMC database to reflect the up-to-date regulatory CMC requirements
- Contribute to knowledge sharing, training, and continuous improvement of China CMC regulatory practices within the organization
Qualifications
- Strong scientific background in Chemistry, Pharmaceutics, Biology, or related discipline, master’s degree or above
- Solid knowledge of pharmaceutical development, manufacturing, and GMP principles
- 5 years or above in CMC Regulatory / pharma development / QC/QA
- Strong communication skills in English and Chinese, with the ability to work effectively in cross-functional and global teams
- Experience with China regulatory CMC requirements is highly desirable; exposure to global regulatory environments or education background in oversea university is a preferred