RESPONSIBILITIES:
1.Provide regulatory input to supervisor for decision making on registration filing strategies.
2.Manage regulatory submissions process and compliance with regulation and guideline.
3.Prepare high quality submission packages for variations, license renewal, annual report, clinical trials and new drug applications within timeline, ensure well implement.
4.Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule.
5.Develop and maintain tracking system for registration procedure to ensure clear registration status; timely report to the line manager.
6.Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient.
7.Provide regulatory support to Medical and Marketing team as well as other company personnel.
8.Review promotion materials according to the internal SOP.
9.Communicate with global/regional RA & local functions to keep the effective registrations, contribute to continuous supply.
10.Establish and maintain good working relationships with regulatory authorities (NMPA, CDE, CFDI, institute for drug control, and so on) to guarantee effective product registrations.
11.Follow up policy change related to business in terms of RA and share with cross-functions timely.
12.Assist supervisor to complete urgent assignments as required in a timely manner.
MORE SPECIFIC INTRODUCTION
1.Therapeutic areas: Gastroenterology.
2.The work includes both life cycle maintenance and new product development
3.Product type is mostly small molecule (chemical drug, both innovative and generic ones).
