Regulatory Affairs Manager

Major Responsibilities：

• Provide regulatory inputs in new project development strategy discussion;
• Lead or coordinate both local and global team on registration plan;
• Be accountable on the implementation the decided project registration strategy by projects planning and tracking  
• 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;
• Be accountable on the communication with Global team on the related regulatory issues on the responsible projects. 
• Review/approve of promotional materials and press releases for NP4 Managerial (MCC review);
• Be accountable to provide the input to Cx plan;
• Be accountable to provide regulatory support to other functional team;
• Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI，PSUR, RMP, registration master file and timely update in DRAGON;
• 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 ;
• Acting as deputy in  the absence of the department head and lead team daily operation

Requirement：

• Bachelor or above with Pharmaceutical/Medical background
• Fluency in English and Chinese  (oral and written)
• At least 6 years in RA and/or  drug/biologic development ;which include 4-5 years and above of demonstrated accomplishment in RA filed;
• The experience in filing global trial CTA independently;
• The experience in filing and obtaining NDA approval;
• The experience in various types of regulatory submission/ approv-als;
• The experience in oncology product submission is a plus