Regulatory senior manager

• Perform periodical internal audit, identify compliance process gaps, understand criticality of gaps and build a roadmap for improving compliance controls, design of process changes to implement business controls. • Provide guidance in risk assessment, identify compliance impact to Life Science and provide recommendations to mitigate potential risk. Take active role to represent company in delicate or risk potential matters with authorities, inspectors and trade associations. • Periodical compliance risk review and reporting to regional / global regulatory, and local business team. • Ensure set up KPIs in alignment with business requirement, and the efficiency of KPIs tracking. • Implement global regulatory management policy and best practice procedures. Provide policy direction, advice and guidance to Commercial, Product Management, Quality, Manufacturing sites, Distribution, Trade Compliance, etc.

职位描述

Delilia Li