DRA Associate Manager

Major Responsibilities：

• 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

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.