Full-time

Regulatory Publishing Expert/Lead

Posted by ProductLife Group • United States, United States, United States

📍 United States, United States 🕒 March 01, 2026

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About the Role

As a Regulatory Publishing Expert/Lead at ProductLife Group, you will ensure compliant, timely, and high‑quality electronic submissions across global health authorities, including INDs, NDAs, BLAs, DMFs, and life‑cycle maintenance activities. You will act as a hands‑on publishing expert and a trusted partner to clients—coordinating internal publishers and PLG resources, maintaining validated tools and SOPs, and upholding best practices aligned with current regulations and guidance.
Responsibilities:
End‑to‑end eCTD/electronic submission publishing for initial and life‑cycle submissions (e.g., INDs, NDAs, BLAs, DMFs), including structure build, validation, finalization, and dispatch to agencies/portals.

Operational ownership of publishing platforms (e.g., Lorenz DocuBridge, EXTEDO)—version upgrades, user acceptance testing (UAT), license/access administration, and vendor liaison.

Maintenance of validated systems: change control, pe...
                

Job Details

Location United States, United States
Job Type Full-time
Category Business Operations Specialists
Posted March 01, 2026
Deadline April 10, 2026

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