Remote Regulatory Submissions Lead — Docs & Publishing

Cardinal Health; Topeka (KS); On-site; USD 36,000 - 47,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Paid time off plan

Health savings account (HSA)

401k savings plan

Flexible spending accounts (FSAs)

Disability coverage

Work-Life resources

Paid parental leave

Job summary

Cardinal Health has an opening for a Senior Coordinator in Regulatory Submissions Operations. This remote role supports US-wide regulatory submissions, formatting and compiling documents, and ensuring version control across databases.

The candidate will manage timelines, client documents, and publishing workflows within a compliant environment. The role emphasizes meticulous editing, strong communication, and collaboration with cross-functional teams to ensure timely drug registration

Qualifications

• Advanced formatting of Microsoft Word documents
• Formatting and editing Adobe documents
• Familiarity with Excel
• Publishing experience in eCTD preferred
• Project management experience is a plus
• Attention to detail
• Strong written and oral communication skills

Responsibilities

• Format, edit and compile paper and electronic documents for regulatory submissions.
• Prepare specialized electronic files for drug registrations.
• Oversee document management databases for version and revision control.
• Assess and negotiate timelines; manage client documents used in submissions.
• Process client documents within publishing software; communicate with partners.

Job description

Cardinal Health has an opening for a Senior Coordinator in Regulatory Submissions Operations. This remote role supports US-wide regulatory submissions, formatting and compiling documents, and ensuring version control across databases.

The candidate will manage timelines, client documents, and publishing workflows within a compliant environment. The role emphasizes meticulous editing, strong communication, and collaboration with cross-functional teams to ensure timely drug registration