職位描述
Talent@Boehringer Ingelheim 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 organise & implement the registration work based on China's registration regulations with the objective of 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 & SFDA approval process to obtain the approval duly. -Registration dossier management-Involve in devising strategies.-Implement DRA SOP and other harmonization work in DRAQualifications -Education/Degree Requirements: Bachelors degree or above (e.g. MBA, MSc)
-Major: Pharmaceutics, Chemistry, Biology or similar preferred -Language skills & proficiency: Good written and oral communication skills in the English language -Required capabilities (skills, experience, competencies): 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
