Regulatory, Quality and Clinical
Conduct as requested regulatory activities
Organize and maintain regulatory database, files and tracking sheets. Ensure appropriate archiving of all relevant documentation in the appropriate systems
Acquire knowledge of the local regulatory requirements in relation to projects assigned
Interacts closely with local/regional/global RA, manufacturing sites and others to obtain data required for projects assigned
Ensure compliance with local regulations and corporate policies and procedures as directed
Maintains and provides required documents for proper functioning of the company
Identify improvement areas in Asian Distribution Center process and coordinate improvement projects.
Monitor 3rd party suppliers with regards to operational efficiency and service levels through monthly reporting.
Provide training to staff and 3PL, in order to improve product quality and customer satisfaction.
Conduct customer satisfaction survey (internal customers).
Co-ordinate with Corporate to look for solutions for systems improvement.
Be the author or approver of quality and operational procedures in Asian Distribution Center.
Responsible for documents control, keep and maintain all quality control documents and procedures.
Communicate with Regional Quality and Regional Logistics Group for quality development in Asian Distribution Center.
Bachelor’s degree in health-related science, life science; Pharmacy or Medical degree desirable
1-2 years experience in Medical affairs is an advantage
Basic understanding of fundamentals of pharmaceutical development and/or pharmaceutical manufacturing desirable
Good English and Chinese communication skills (both oral and written)
Able to multitask and to work to tight deadlines
Highly diligent working approach, detail oriented and structured approach to collection, collation and communication of technical requirements for regulatory submissions and for database filings