Senior Specialist, Regulatory Affairs

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
- Implement the registration plan based on China's registration regulations with the supervision of line manager.
- Prepare and submit the registration dossier for new products, IDL(Import Drug License) renewal and variation application.
- Follow up and push the review process to obtain the approval duly.
- Work closely with cross-functional colleagues.
- Know registration requirements and knowledge sharing.
- Handle other non-project related issues.

Job Requirements
- Bachelor degree or above (e.g. MBA, MSc) in Pharmaceutics, Chemistry, Biology or other relevant major is preferred.
- 1~2 years' international company registration working experience. Or less than 1 year's registration working experience in international company plus but have more than 2 years registration related working experience in local company.
- Detail oriented, well organized, and work well under pressure. Strong learning ability.
- Good personalities with team spirit.
- Interpersonal and communication skills are also required.