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.
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, 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.
Experience
Education & Experience
• 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).
Technical Expertise
• 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.
Apply Now
Apply Now
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, 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.
Experience
Education & Experience
• 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).
Technical Expertise
• 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.
Apply Now
Apply Now