Job Information
Boehringer Ingelheim AM, Regulatory Affairs - Cardiovascular in Shanghai, China
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
To organize & implement the registration work based on China's registration regulations with the objective of meeting Boehringer Ingelheim China's products registration timeline.
Work independently on projects, communicate with HQ of company to request registration documents and samples.
Prepare and submit the registration dossier for new products, IDL renewal and variation application.
Follow up and push QC test, CDE review & NMPA approval process to obtain the approval timely.
Registration dossier management
Implement Drug Regulatory Authority SOPs.
Other harmonization work in Drug Regulatory Authority.
Job Requirements
Bachelor degree or above (e.g. MBA, MSc), major in Pharmaceutics, Chemistry, Biology or other relevant major is preferred.
Strong learning ability.
Good project management skill and experience. Be able to work with a keen sense of urgency and priority.
Good relationship & experience with relevant authorities is preferred.
Good personalities with team spirit.
Good interpersonal and communication skills.
At least 5 years import drug registration working experiences.
All qualified applicants will receive consideration for employment without regard to a person’s actual or perceived race, including natural hairstyles, hair texture and protective hairstyles; color; creed; religion; national origin; age; ancestry; citizenship status, marital status; gender, gender identity or expression; sexual orientation, mental, physical or intellectual disability, veteran status; pregnancy, childbirth or related medical condition; genetic information (including the refusal to submit to genetic testing) or any other class or characteristic protected by applicable law.
Boehringer Ingelheim
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