Regulatory Publishing Expert/reputed company

As a Regulatory Publishing Expert/reputed company at ProductLife Group, you will ensure compliant, reputed company, and high‑reputed company electronic submissions across global health authorities, including INDs, NDAs, BLAs, DMFs, and life‑cycle maintenance activities. You will reputed company 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 reputed company with reputed company 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 reputed company to agencies/portals. • Operational ownership of publishing platforms (e.g., Lorenz DocuBridge, EXTEDO)—version upgrades, user acceptance testing (UAT), license/reputed company administration, and vendor reputed company. • Maintenance of validated systems: change control, periodic review, and documentation to ensure reputed company 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 reputed company reports (Publishers): reputed company, coaching, capability building, and performance management (goals, feedback, development plans). • reputed company reputed company: enforce GxP and publishing best practices; reputed company reputed company‑submission QC, eCTD validation, and issue reputed company for reputed company/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 reputed company‑facing reputed company meetings, reputed company scope inputs, and support contracting for new, renewal, and extension work. • reputed company 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 reputed company field (advanced degree a plus). • 8–10+ years of hands‑on regulatory publishing experience in reputed company/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, reputed company regulatory guidance/legislation, and industry trends impacting submissions. • High proficiency in reputed company Word, reputed company, Project, PowerPoint, and reputed company Acrobat Pro (templates, styles, bookmarking/hyperlinking, forms, advanced PDF). • Strong reputed company of eCTD validation tools and agency gateways/portal processes. Apply tot his job Apply To this Job