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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.
Job Responsibility:
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
Requirements:
Bachelor’s degree (BA/BS) in Life Sciences or related field (advanced degree a plus)
8–10+ years of hands-on regulatory publishing experience in pharma/biotech or consulting (global programs
NDA/BLA/MAA experience a plus)
Proficiency with electronic publishing software (e.g., Lorenz DocuBridge, EXTEDO), including configuration, software updates, and user administration
Deep familiarity with eCTD standards, GxPs, current regulatory guidance/legislation, and industry trends impacting submissions
High proficiency in Microsoft Word, Excel, Project, PowerPoint, and Adobe Acrobat Pro (templates, styles, bookmarking/hyperlinking, forms, advanced PDF)
Strong command of eCTD validation tools and agency gateways/portal processes