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About AbbVie

AbbVie (NYSE:ABBV) is a global, research-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world’s most complex and critical conditions. The company’s mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world.  For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook or LinkedIn.​

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Regulatory Affairs Manager

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Regulatory Affairs
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1905801 Requisition #
Join our Talent Community

 

  • Develop regulatory strategies, plans and timelines, to ensure successful new registrations and effective product maintenances, in line with local business objectives.Manage regulatory submissions process, prepare high quality submission packages and responses to deficiency questions within applicable timelines.Work closely and swiftly with cross-functional and brand teams to update regulatory projects, address critical issues and potential solutions.
  • Provide regulatory advices and supports to business personnel, including tender.Review labeling, promotional and educational materials to ensure compliance.Monitor and forecast regulatory environment periodically, and assess impact to AbbVie business.
  • Liaise with drug authorities for insights into current activities and future direction of regulation.Develop and maintain regulatory operation processes and systems to support regulatory submissions and approvals in the most efficient.Develop and manage product registration database to ensure information transmission timely and accurately.
  • Develop, compile and update local SOP on quality management systems, quality accountabilities and working methods.Handle non-medical complaints according to local SOP.Manage cold chain according to global SOP.
  • Conduct management review quarterly.Update package inserts, corresponding overlabels and finished product labels, ensure reviews and approvals in a timely manner.Review and release finished products with proper labeling.
  • Develop and manage product quality database to ensure information transmission timely and accurately.Lead audit activities for QA/RA functions as required.Support PV audit.

 

 

  • Education:Bachelor degree or above in pharmacy or related science. Master degree is preferred.At least 5 years regulatory affairs experience in pharmaceutical or biotech industry.Working experience with multinational company.Experience with new chemical entities (NCE), biologics and clinical trial application.Familiar with regulatory guidelines and requirements.Project management skill.
  • Adaptability:Try to understand changes.Treat changes and new situations positively.Adjust behavior to deal with changes.
  • Initiative:Respond quickly & being proactive.Implement new ideas or potential solutions without prompting.Take action that goes beyond job requirements in order to achieve objectives.
  • Integrity:Maintain, promote social & ethical norms.Adhere to codes of conduct & ethical principles.
  • Innovation:Generate innovative solutions in work situations.Draw multiple sources for ideas and inspiration.Try different & novel ways to deal with work problems.
  • Teamwork:Share important or relevant information with the team.Listen to & fully involve others in team decisions & actions.Establish & maintain good working relationships with others.
  • Work Standard:Set standards for excellence.Ensure high quality.Take responsibility.

 

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