Shanghai, CHN
58 days ago
Associate Regulatory Affairs Manager
**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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