Regulatory Affairs Manager

Major Responsibilities：

• Establish regulatory function for OTM China, working under the guidance of the Director of DRA, OBU China and closely with the Global DRA Head for OTM;
• Provide regulatory inputs for new project development strategy discussion in China, working with global OTM DRA colleagues;
• Lead or coordinate both local and global team on CTA strategy and implementation, specifically for China and other AP countries;
• Be accountable to supervise the direct reports on the implementation of the project regulatory strategy by projects planning and tracking, and project executions;  
• Be accountable on achieving the target timeline of submission and approval;
• Be accountable on the communication with HAs to properly address the concerns on projects; and the coordination on related HA meetings;
• Skilful on the internal cross function communication in local team and  Global team on the related regulatory issues on the responsible projects. 
• Be accountable to provide regulatory support to other functional team ;
• Be accountable for ensuring regulatory compliance for the responsible project-related activities, like, maintenance of CTA-related submissions, and give input to relative WIs or SOPs updates
• Ensure regulatory activities comply with Novartis internal Code of Conduct and SOPs during routine work;
• Monitor regulatory changes and report to department head timely
• Provide/Assist department head to coach the junior levels ;
• Other appointed tasks

Requirement：

• At least 6 years of
• demonstrated accomplishment in RA field;
• The experience in filing and obtaining approval for local or global trial CTA independently;
• Skillful for cross function communications for regulatory affairs
• Have experience for SOPs and WI updates
• The experience in oncology product submission is a plus
• Experience with CRO management is a plus
• Experience with early phase clinical trial application is a plus
• The experience in filing and obtaining NDA approval is a plus