Major Responsibilities/Activities:

• Provide regulatory input to supervisor for decision making on registration filing strategies.
• Set up product registration timeline and ensure well implement.
• Prepare and validate registration dossier to ensure fully meet Chinese regulations and guildlines.
• Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule.
• Develop and maintain tracking system for registration procedure to ensure clear registration status; timely report to the line manager.
• Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient.
• Provide regulatory support to Medical and Marketing team as well as other company personnel.
• Review promotion materials according to the internal SOP.
• Communicate with area regional/global RA & local functions to keep the effective registrations, and ensure no delay for the market supply due to IDL renewal.
• Establish and maintain good working relationships with regulatory authorities (NMPA, CDE, institute for drug control, and so on) to guarantee effective product registrations.
• Follow up policy change related to business in terms of RA and share with cross-functions timely.
• Assist supervisor to complete urgent assignments as required in a timely manner.