Key Responsibilities
Responsible to proactively develop innovative, robust regulatory strategies in Greater China and ensure their efficient and effective execution for pipeline and lifecycle assets in clinical development in Ｏncology, Immunology and Infectious diseases
Ensure timely and high quality submissions
Provide guidance and oversight for health authority interactions/meetings
Provide input to global regulatory strategies for each project within the Therapeutic area(s)
Direct the team efforts required for the submission of INDs, BLAs, sBLAs as well as related supplements and annual reports
Represent the RA department Ｏn internal cross-functional teams for activities such as SOP development, business process improvements, etc.
Regulatory representative Ｏn due diligence activities for external development candidates
Coach and mentor junior members in their roles Ｏn global project teams and as the leader of regional regulatory team
Have an understanding of the competitive environment of the various indications in Ｏncology, Immunology and Infectious diseases
Provides regular and timely updates to senior management Ｏn the status of all pending applications and planned submissions as necessary

Qualifications
Minimum M.S. degree in life/health sciences required
A minimum of 10 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Authorization Applications
In depth knowledge of China regulatory guidelines and knowledge of global regulatory requirements
Ability to work independently within project teams, committees, etc. to attain group goals
Demonstrate excellent communication skills