RA Manager

The company focuses on the development, production, and commercialization of mAb biosimilar drugs, bio-betters and novel mAbs using cutting-edge technology. Products currently in development cover a variety of therapeutic areas including oncology and autoimmune diseases. Our R&D management team has extensive experience in the development and commercialization of a range of monoclonal antibody drugs in such leading international pharmaceutical and biotech companies as Genentech, Amgen, BMS and Eli Lilly. The concept of our drug development lies in global integrative innovation, and we have 3 R&D laboratories located in China (Shanghai), the US (California) and Taiwan (Taipei).

Job Responsibilities

• Receive project assignments from manager but has responsibility for managing timelines for​ projects with minimal supervision required;
• Provide recommendations on project decisions and make recommendations for improvements;
• Steer projects and communicate to manager any issues that would result in a delay;
• Work with internal colleagues, external consultants and Health Authorities (HAs);
• Compliant with applicable policies, procedures, and other regulations.
• Review, compile, and submit IND, CTA, BLA applications, supplements, and amendments;
• Provide regulatory inputs for new project development strategy discussion;
• Accountable to supervise the direct reports on the implementation of the project regulatory strategy by projects planning and tracking and project executions;  
• Accountable for achieving the target timeline of submission and approval;
• Accountable for the communication with Health Authorities (HAs) to properly address the concerns on projects; and the coordination of related HA meetings;
• Maintain a good relationship with HAs;
• Communicate with internal cross functional team on the related regulatory issues on the responsible projects; 
• Accountable to provide regulatory support to other functional teams;
• 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;
• Monitor regulatory changes and report to department head timely;
• Provide/Assist department head to coach the junior levels;
• Other appointed tasks

Qualification 

• At least 8 years of life science industry experience post bachelor’s degree, with at least 5  years of demonstrated accomplishment in RA field; or at least 5 years life science industry experience postmaster's degree; or at least 2 years life science industry experience post Doctor’s degree;
• The experience in filing and obtaining approval for local or global trial IND/CTA independently;
• Skills of cross-functional communications within the company;
• Experience in HAs interactions;
• Experience with SOPs and WI updates;
• Experience in biologics such as mAb product submission is a plus;
• Experience with electronic submission is a plus;
• Experience with CRO management is a plus;
• Experience in filing and obtaining NDA/BLA approval is a plus.