Global Regulatory Submissions Lead (eCTD) - Remote

Eliassen Group; Hagåtña (GU); Remote; USD 90,000 - 103,000; Part time

Benefits offered by this job

Medical, Dental, Vision benefits

401k with company matching

Life insurance

Job summary

Eliassen Group is seeking a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high profile molecules. The role reports to the Head of Regulatory Operations Clinical and Publishing for Global Submissions and may assist with secondary publishing when workload requires.

This is a remote, contract position with a W2 arrangement. Competitive benefits include Medical, Dental, Vision, 401k with company matching, and life insurance.

Qualifications

• 7+ years of direct regulatory experience in pharma.
• Global eCTD submission planning and management across Modules 1-5 and regions (US, EU, Canada).
• Experience with Veeva Vault RIM and strong project management capabilities.

Responsibilities

• Lead registration planning and execution for global submissions.
• Manage eCTD submissions across CTD Modules 1-5 and multiple regions.
• Coordinate with global teams to incorporate local regulatory requirements.
• Advise development teams on submission processes and regulatory needs.
• Own molecule-/project-level registration management and tracking.
• Oversee routine submissions (DSUR, NDA/BLA annual reports, PSUR/PADER).
• Support secondary publishing for Modules 1-5 content when needed.

Skills

Regulatory ops

Project management

eCTD knowledge

Veeva Vault

Global submissions

Communication

Team collaboration

Education

BS in a technical discipline such as chemistry, biology, or pharmacy

Tools

Veeva Vault RIM

Job description

Eliassen Group is seeking a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high profile molecules. The role reports to the Head of Regulatory Operations Clinical and Publishing for Global Submissions and may assist with secondary publishing when workload requires.

This is a remote, contract position with a W2 arrangement. Competitive benefits include Medical, Dental, Vision, 401k with company matching, and life insurance.