Remote Global Regulatory Submissions Lead – eCTD Strategy

Eliassen Group; Dover (DE); On-site; USD 186,252,000 - 214,906,000; Full time

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

401k with match

Job summary

Eliassen Group is seeking a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high-profile molecules. This remote, contract role focuses on operational submission content planning for Modules 1-5 and coordinates across geographies to ensure compliance with evolving eCTD requirements.

Reporting to the Head of Regulatory Operations Clinical and Publishing for Global Submissions, you will drive submission planning sessions, track statuses, and support

Qualifications

• 7+ years of direct regulatory experience in pharma.
• Global eCTD submission planning & management across US, EU, Canada.
• Experience with ICH guidelines.
• Able to provide secondary publishing support for eCTD.
• Strong project management, written and verbal communication.

Responsibilities

• Serve as regulatory operational lead for registration planning and execution.
• Lead submission management for CTD modules and multiple submission types.
• Partner with global teams to incorporate local agency requirements.
• Guide development teams on registration processes and requirements.
• Own registration management at molecule/project level with tracking of status.
• Handle routine DSUR, NDA/BLA annual reports, PSUR/PADER submissions.
• Collaborate with regulatory coordinators/scientists on product changes.
• Support secondary publishing for content plans (Modules 1-5).

Skills

Regulatory Operations

Project Management

eCTD

Global Submissions

Veeva Vault RIM

Teamwork

Communication

Education

BS in chemistry/biology/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. This remote, contract role focuses on operational submission content planning for Modules 1-5 and coordinates across geographies to ensure compliance with evolving eCTD requirements.

Reporting to the Head of Regulatory Operations Clinical and Publishing for Global Submissions, you will drive submission planning sessions, track statuses, and support