China Job Openings
Boehringer Ingelheim (China) Investment Co., Ltd.
Nonclinical Safety Expert
November 1, 2024
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
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
- To provide the support for the NDS sections of dossiers for China CTA/ NDA submissions
- Work with global NDS experts and local project teams in preparing the non-clinical/ safety related documents/ dossiers in defined timeline to support the CTA/NDA submissions and regulatory interactions including pre-IND and pre-NDA communications, in China for both new chemical and biological entities; ensure the quality of the non-clinical/ safety submission documents (e.g., proofreading of the translations)
- Understand and provide the China regulations on non-clinical/ safety studies at pre-clinical and clinical development stages to global teams in order to ensure the compliance
- Liaise with China Health Authorities and/or relevant consortia (e.g., RDPAC) for knowledge sharing and policy evolution participation
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Explore the potential external collaboration opportunities for non-clinical/ safety studies in China; understand the needs from global Development and work with the team in innovation scouting for non-clinical/ safety/ pathology as applicable
Job Requirements
- Ph D (in biochemistry, biology, or chemistry), DVM (Doctor of Veterinary Medicine), MD or equivalent degree from an accredited institution with 4+ years related experience, or relevant MS degree and 7+ years related experience.
- At least 3 years of experience in regulatory supporting activities in China with regard to non-clinical/clinical safety studies, preferably in pharmaceutical industry
- Demonstrates solid knowledge in field of toxicology. Candidate possesses practical knowledge of pharmaceutical toxicology including approaches to development toxicology, relevant regulatory guidelines and preparation of submission documentation.
- Having understanding/ knowledge/experiences in DMPK is a plus
- Demonstrated ability to work effectively in a team environment.
- Entrepreneurial thinking and can-do attitude
- Strong interpersonal & communication skills
- Excellent ability to communicate effectively both orally and in writing in an interdisciplinary environment.
- Fluent in both Chinese and English
- Willingness to travel on as needed (Germany, US, China)
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