Regulatory Publishing Expert/Lead

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.

• 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, periodic review, and documentation to ensure continuous inspection readiness (QMS, SOPs, WI, templates).
• Workload planning & delegation across internal publishers and PLG partners/contractors; balancing priorities and reallocating work to hit critical milestones.
• People leadership of direct reports (Publishers): onboarding, coaching, capability building, and performance management (goals, feedback, development plans).
• Quality oversight: enforce GxP and publishing best practices; lead pre‑submission QC, eCTD validation, and issue resolution for complex/variable factors.
• Cross‑functional collaboration with Regulatory Affairs, CMC, Clinical, QA, and external clients to drive on‑time, right‑first‑time submissions.
• Business development support: participate in client‑facing BD meetings, provide scope inputs, and support contracting for new, renewal, and extension work.
• Continuous improvement: monitor industry trends, tools, and guidance; propose process/technology enhancements and training curricula.