Job Information
Abbott Associate Regulatory Affairs Manager in Shanghai, China
Major Responsibilities/Activities:
Provide regulatory input to supervisor for decision making on registration filing strategies.
Set up product registration timeline and ensure well implement.
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; timely report to the line manager.
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 regional/global 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 (NMPA, 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.
Assist supervisor to complete urgent assignments as required in a timely manner.
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email corpjat@abbott.com