Eisai US

Associate Director, Global Submission Management

Eisai US(2 months ago)

HybridFull TimeDirector$159,000 - $208,700Global Regulatory Operations
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About this role

The Associate Director, Global Submission Management at Eisai leads and oversees the planning, preparation, coordination and delivery of global regulatory submissions to ensure compliance with applicable regulations and standards. The role focuses on strategic alignment and process optimization across regions, supporting Global Regulatory Operations and enabling timely submission timelines through follow-the-sun processes. This position supports cross-regional collaboration and represents GSM within the organization and with external agencies and vendors.

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Required Skills

  • eCTD Publishing
  • RIM Systems
  • Document Management
  • Project Management
  • Submissions Management
  • Regulatory Compliance
  • Cross-Functional Leadership
  • Process Improvement
  • Vendor Management
  • Timeline Planning

+4 more

Qualifications

  • Bachelor's Degree in Scientific or Information Technology Field
  • Advanced Degree Preferred
  • RAPS Certification (Preferred)
Eisai US

About Eisai US

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