Global eCTD Submissions Lead (Remote)

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

Job summary

Eliassen Group is seeking a Regulatory Operations Project Manager to lead global eCTD submissions planning and management. This remote contract role focuses on Modules 1-5, coordinating across geographies to ensure evolving eCTD compliance and timely submissions.

The candidate will manage registration across CTD modules, support secondary publishing, and partner with global teams. 7+ years in pharma regulatory operations and Veeva Vault RIM experience are preferred.

Qualifications

• 7+ years of direct regulatory experience in pharma.
• Global eCTD submission planning across US, EU and Canada.
• Experience with Veeva Vault RIM.
• Strong project management skills.
• Knowledge of drug development processes and regulatory strategies.
• Excellent written, spoken, and presentation communication.
• Ability to work ET schedule with after-hours flexibility.

Responsibilities

• Serve as regulatory operational lead for registration planning and execution.
• Lead registration management for global submissions across CTD modules and submission types.
• Coordinate with global teams to incorporate local agency requirements.
• Guide development teams on internal and agency registration processes.
• Own registration management at molecule/project level with compliant records.
• Handle routine compliance submissions (DSUR, NDA/BLA annual reports, PSUR/PADER).
• Support secondary publishing and content plans for Modules 1-5 as needed.

Skills

Regulatory Operations

Project management

Global submissions

Communication

Teamwork

ICH guidelines

Education

BS in a technical discipline (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. This remote contract role focuses on Modules 1-5, coordinating across geographies to ensure evolving eCTD compliance and timely submissions.

The candidate will manage registration across CTD modules, support secondary publishing, and partner with global teams. 7+ years in pharma regulatory operations and Veeva Vault RIM experience are preferred.