Regulatory Publishing Expert/Lead

ProductLife Group; United States; On-site; USD 100,000 - 130,000; Full time

Job summary

A leading regulatory consulting firm in the United States seeks a Regulatory Publishing Expert/Lead. The ideal candidate will ensure compliant and high-quality electronic submissions across global health authorities. Responsibilities include end-to-end publishing for submissions, operational ownership of platforms, maintaining validated systems, and people leadership. Candidates should possess 8–10+ years of experience in regulatory publishing and a Bachelor's degree in Life Sciences. This role involves cross-functional collaboration and quality oversight in a fast-paced environment.

Qualifications

• 8–10+ years of hands-on regulatory publishing experience in pharma/biotech or consulting.
• Deep familiarity with eCTD standards and regulatory guidance.

Responsibilities

• End-to-end eCTD/electronic submission publishing for initial and life-cycle submissions.
• Operational ownership of publishing platforms including version upgrades.
• Quality oversight with enforcement of GxP and publishing best practices.

Skills

Regulatory publishing experience

Cross-functional collaboration

Quality oversight

People leadership

Business development support

Education

Bachelor’s degree in Life Sciences

Advanced degree

Tools

Lorenz DocuBridge

EXTEDO

Microsoft Word

Microsoft Excel

Adobe Acrobat Pro

Job description

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.

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.