Regulatory Affairs Manager
Current·Provide regulatory input to supervisor for decision making on registration filing strategies. Set up product registration timeline and ensure well implement. ·Define regulatory strategies for the registration of BD products. Provide regulatory expertise to business partners(e.g.Commercial,BD,Manufacturing, product development and etc.) ·Prepare and validate registration dossier to ensure fully meet Chinese regulations and guildlines. ·Track on-going projects and handle technical issues from regulatory authorities to achieve registration approvals on schedule. ·Develop and maintain tracking system for registration procedure to ensure clear registration status. •Develop and implement internal processes and system to support regulatory submissions and approvals in the most efficient. ·Provide regulatory support to Medical and Marketing team as well as other company personnel Communicate with regional/global RA & local functions to keep the effective registrations,and ensure no delay for the market supply ·Establish and maintain good working relationships with regulatory authorities (NMPA,CMDE) to guarantee effective product registrations. ·Follow up policy change related to business in terms of RA and share with cross-functions timely. ·Train and develop subordinates, provide good supports, well coordinate with colleagues,and create positive working environment to promote the best performance•Establish internal SOP and WI. ·Assist supervisor to complete urgent assignments as required in a timely manner.
