Regulatory Affairs Submission Management Specialist

7 days ago


North Chicago, Illinois, United States US Tech Solutions Full time
About the Role

US Tech Solutions is seeking a highly skilled Regulatory Affairs Submission Management professional to join our team. As a key member of our regulatory affairs team, you will be responsible for managing low to medium impact submission projects, ensuring timely delivery of high-quality dossiers that meet technical specifications defined by regulatory authorities.

Key Responsibilities
  • Manage submission projects to ensure timely delivery of high-quality dossiers
  • 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 provide notification to ensure all required resources are available to meet submission timelines
Requirements
  • Bachelor's Degree
  • Two years pharmaceutical or industry-related experience
  • Preferred experience in publishing-related software tools, such as Documentum, eCTDXPress/ISIPublisher, ISI Toolbox/DocuBridge/Insight platform, 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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