DRA Associate manager

Basic Purpose of the Position：

•  IND & NDA, IDL maintenance, Variation application, etc.
•  (Int’l CTA, Rx IM, Rx CRC, CCDS, CNS/Respiration/CV)

Accountabilities:

•  Focus on PM projects, communicate with HQ of company to request registration documents and samples.
•  Work independently to 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.
•  Maintain internal DRA system.
•  Implement DRA sop.
•   Other harmonization work in DRA

Skills & Competencies Requirement:

•  Bachelors degree，Masters degree (e.g. MBA, MSc)；Pharmaceuticals，Chemistry，Biology
•  More than 5 years import drug registration working experiences
•  Good relationship & experience with relevant authorities is preferred;
•  Must be extremely detail oriented, well organized, and work well under pressure. Strong learning ability;
•  Good personalities with team spirit;
•  Interpersonal and communication skills are also required.