Remote eCTD Submissions Lead — Regulatory Operations

Eliassen Group; Augusta (ME); On-site; USD 90,000 - 103,000; Full time

Benefits offered by this job

Medical, Dental, and 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 position focuses on Modules 1-5 content planning and coordination across geographies to ensure compliance with evolving eCTD requirements.

The role reports to the Head of Regulatory Operations Clinical and Publishing for Global Submissions and may assist with secondary publishing when workload demands.

Qualifications

• 7+ years of direct regulatory experience in pharma with robust 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.

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

eCTD submissions

Global cross-functional collaboration

Veeva Vault RIM

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. The position focuses on Modules 1-5 content planning and coordination across geographies to ensure compliance with evolving eCTD requirements.

The role reports to the Head of Regulatory Operations Clinical and Publishing for Global Submissions and may assist with secondary publishing when workload demands.