Medical and Regulatory Affairs
- Assist Regulatory manager for implementing and delivering regulatory submission and approval, and maintenance for new products / projects in assigned therapeutic area within agreed timeline.
- Ensure regulatory compliance with government policy and company required SOPs
- Establish and maintain close relationship with CFDA/ CDE/ NICPBP/ Shanghai FDA/ Shanghai DCI and other appropriate regulatory agencies and under manager’s guidance have a close/ effective communication with relevant regulatory agencies to consult regulatory strategy, determine status and facilitate the approvals of applications submitted to CFDA.
- Conduct scientific discussion under guidance of supervisor with relevant external and internal scientific functions locally and globally, specifically, Global and China Clinical Research, global CMC and GRS Operation, Pharmaceutical Development, Pre-Clinical, etc.
- Maintain good knowledge on general/product specific scientific and regulatory requirement / process
- Maintain strong working relationship and communications with cross-functions to provide regulatory information and support