Global eCTD Submissions Lead (Remote)

Eliassen Group; Juneau (AK); On-site; USD 90,000 - 103,000; Part time

Benefits offered by this job

Medical benefits

401(k) with match

Life insurance

Job summary

Eliassen Group is seeking an experienced Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high-profile molecules. This remote contract role focuses on Modules 1-5 content planning, coordinating international submissions, and ensuring compliance with evolving eCTD requirements.

Responsibilities include leading registration planning, collaborating with global teams, and supporting secondary publishing as workload demands.

Qualifications

• 7+ years of direct regulatory experience in pharma or life sciences.
• Global eCTD submission planning and management across modules 1-5 and multiple regions.
• Experience with Veeva Vault RIM.
• Strong project management skills.
• Knowledge of drug development processes and regulatory strategies.
• Excellent written, spoken, and presentation communication.
• Demonstrated teamwork and adaptability to diverse styles.
• Ability to provide secondary publishing support for eCTD submissions.

Responsibilities

• Serve as the regulatory operational lead for registration planning and execution across sessions and meetings.
• Lead registration management for global submissions across CTD modules and submission types.
• Coordinate with global teams to incorporate local agency regulations.
• Guide development teams on registration processes and requirements.
• Own registration management at molecule or project level with accurate records and timelines.
• Manage routine compliance submissions (DSUR, NDA/BLA annual reports, PSUR/PADER).
• Support product deletion, inactivation, or withdrawal processes.
• Assist with secondary publishing of Modules 1-5 content as needed.

Skills

Regulatory Operations

Global eCTD planning

Project management

Veeva Vault RIM

Drug development knowledge

Communication

Teamwork

Secondary publishing

Education

BS in Chemistry/Biology/Pharmacy

Tools

Veeva Vault RIM

Job description

Eliassen Group is seeking an experienced Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high-profile molecules. This remote contract role focuses on Modules 1-5 content planning, coordinating international submissions, and ensuring compliance with evolving eCTD requirements.

Responsibilities include leading registration planning, collaborating with global teams, and supporting secondary publishing as workload demands.