Associate Manager, Regulatory Affairs (上海, 中国)

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

-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 DRA sop.

-Other harmonization work in DRA.

Qualifications

-Bachelors degree or above (e.g. MBA, MSc) in Pharmaceutics, Chemistry, Biology or other relevant major

-Good project management skill and experience. Be able to work with a keen sense of urgency and priority. Strong learning ability;

-Good relationship & experience with relevant authorities is preferable

-Good personalities with team spirit;

-Good interpersonal and communication skills.

-At least 5 years import drug registration working experience

-Language skills & proficiency: Good written and oral communication skills in both Chinese and English language

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