Regulatory Affairs Submission Manager

1 week ago


North Chicago, Illinois, United States US Tech Solutions Full time
Job Title: Associate Regulatory Affairs Submission Management

At US Tech Solutions, we are seeking a highly skilled Associate Regulatory Affairs Submission Management professional to join our team.

About the Role:

The Associate Regulatory Affairs Submission Management will be responsible for managing low to medium impact submission projects involving multiple cross-functional regulatory submission teams. This individual will establish and maintain submission content planners and associated timelines, facilitate tactical submission team meetings, prepare content planners for publishing, interface with publishing vendors, and fulfill Submission Management functions on Project Teams in support of Development, Marketing, and post-marketing regulatory authority applications.

Key Responsibilities:
  • Manage low to medium impact submission projects to ensure timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities.
  • Act as RA Submissions support to project teams, providing guidance and communication of established submission processes and standards.
  • Participate in submission team meetings and expedite, manage, and coordinate multiple concurrent interrelated activities for submission projects.
  • Anticipate obstacles and propose solutions within the team, coordinate submission publishing with offsite publishers, and prepare content planners for publishing.
  • Perform detailed quality reviews of published output to ensure compliance with Regulatory Standards and Health Authority guidance.
Requirements:
  • Bachelor's Degree
  • Two years of pharmaceutical or industry-related experience
  • Preferred experience in publishing-related software tools, such as Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, and Adobe Acrobat
About US Tech Solutions:

US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. We are an Equal Opportunity Employer and welcome applications from qualified candidates without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



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