Senior Regulatory Affairs Manager

Role Overview

• Set up regulatory strategy, product registration timeline and ensure well implement
• Prepare and validate registration dossier for CTA, NDA, Renewal and variation to ensure timely approval and fully meet Chinese regulations and guildlines
• Responsible for CTA applications, line extension, license renewal, variation applications (such as CMC changes, safety updates, local repackaging, specification upgrades etc.)
• 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
• Review promotion materials according to the internal SOP
• Communicate with area RA & local functions to keep the effective registrations, and ensure no delay for the market supply due to IDL renewal
• Establish and maintain good working relationships with regulatory authorities (CFDA, CDE, institute for drug control, and so on) 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 of team work
• Establish internal SOP and WI
• Assist supervisor to complete urgent assignments as required in a timely manner.

Requirements

• Over 5 years working experience in regulatory affairs for pharmaceuticals including more than 3 years in the project management post
• Solid registration project management skills
• Effective problem solving and planning capabilities
• Good knowledge of CFDA regulations and guidelines
• Good working relationship with regulatory authorities
• Good command of oral and written English
• Good communication and management skill.

Benefits

• Not specified