Global eCTD Submissions Lead - Remote

Eliassen Group; Salt Lake City (UT); On-site; USD 90,000 - 103,000; Part time

Job summary

Eliassen Group is looking for a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high-profile molecules. You will coordinate across geographies to ensure compliance with evolving eCTD requirements and support secondary publishing as needed.

This contract role requires 7+ years of pharma regulatory experience, strong PM skills, and availability for ET hours with some after-hours and weekend flexibility to align with global teams.

Qualifications

• 7+ years of direct regulatory experience in pharma with strong clinical Regulatory Operations background.
• Global eCTD submission planning and management across Modules 1-5 and regions including US, EU, and Canada, with working knowledge of ICH guidelines.
• Experience with Veeva Vault RIM.
• Strong project management skills.
• Knowledge of drug development processes and regulatory or business strategies and plans.
• Effective written, spoken, and presentation communication.
• Demonstrated teamwork and adaptability to diverse interpersonal styles.
• Ability to provide secondary publishing support for eCTD submissions when required.
• Ability to work a standard Monday through Friday schedule on Eastern Time, with flexibility to support after-hours and some weekends in coordination with global teams.

Responsibilities

• Serve as the regulatory operational lead for registration planning and execution, including planning sessions, status updates, team operations meetings, and department planning.
• Lead registration management by applying expertise in electronic submission regulations, guidance, and technical content for global submissions across all CTD modules and submission types, including Ad Promo, INDs, NDA, BLAs, NDSs, MAAs, renewals, and variations.
• Partner with global teams to incorporate local agency regulations and requirements and to plan and execute submissions in regions adopting eCTD specifications.
• Guide and influence development teams regarding internal and agency registration management processes and requirements.
• Own registration management at the molecule or project level, ensuring electronic records are timely, complete, and accurate, including tracking submission status, commitments, and regulatory communications.
• Own routine compliance submissions and processes for assigned molecules, including DSUR, NDA/BLA annual reports, PSUR/PADER, and routine maintenance submissions.
• Partner with Regulatory Coordinators or Scientists to drive product deletion, divestiture, IND inactivation or withdrawal, and product withdrawal processes.
• Support secondary publishing as needed by retrieving, publishing, and submitting Modules 1-5 content per content plans, including CRFs, datasets, literature references, periodic reports, and post-marketing supplements and amendments.

Skills

Regulatory Operations

Project Management

Global eCTD

Veeva Vault RIM

Regulatory Submissions

Communication

Teamwork

Secondary publishing

Eastern Time schedule

Education

BS in chemistry, biology, or pharmacy

Job description

Eliassen Group is looking for a Regulatory Operations Project Manager to lead global eCTD submissions planning and management for high-profile molecules. You will coordinate across geographies to ensure compliance with evolving eCTD requirements and support secondary publishing as needed.

This contract role requires 7+ years of pharma regulatory experience, strong PM skills, and availability for ET hours with some after-hours and weekend flexibility to align with global teams.