Regulatory Affairs Submission Manager

4 weeks ago


Chicago, Illinois, United States AbbVie Full time
Job Summary

We are seeking a highly skilled Regulatory Affairs Submission Manager to join our team at AbbVie. The successful candidate will be responsible for managing medium to high-impact submission projects, ensuring timely delivery of high-quality dossiers that meet regulatory authority requirements.

Key Responsibilities
  • Manage submission projects, including planning, coordination, and execution, to ensure timely delivery of high-quality dossiers.
  • Act as a liaison between regulatory affairs teams and project teams, providing guidance and communication on established submission processes and standards.
  • Plan and conduct submission team meetings, expediting and managing multiple concurrent activities to meet submission timelines.
  • Coordinate submission publishing with offsite publishers, ensuring all required resources are available to meet submission deadlines.
  • Perform quality reviews of published output to ensure compliance with regulatory standards and health authority guidelines.
  • Suggest and contribute to process improvements, including changes to software and business processes.
Requirements
  • Four years of pharmaceutical or industry-related experience with publishing-related software tools.
  • Preferred experience in Regulatory Affairs, including regulatory submission project management and/or submission publishing.
  • Proven leadership skills and presence.
What We Offer

AbbVie offers a comprehensive package of benefits, including paid time off, medical/dental/vision insurance, and 401(k) to eligible employees. This role is eligible to participate in our short-term incentive programs.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community, and embracing diversity and inclusion.



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