Regulatory Affairs Submission Manager

2 weeks ago


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

About the Role:

We are seeking an experienced Associate Regulatory Affairs Submission Management professional to join our team at US Tech Solutions. 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 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:

  • Required Education: Bachelor's Degree
  • Required Experience: Two years pharmaceutical or industry-related experience
  • Preferred experience: Publishing-related software tools, e.g., 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 committed to delivering exceptional service and expertise to our clients.

Equal Opportunity Employer:

US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.



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