Associate Regulatory Affairs Manager
Abbott
**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
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