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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

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