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Morundakk logo

[Remote] eCTD Publisher Specialist /Sr. Specialist

Morundakk
Posted May 28, 2026, 8:39 AM UTC
🇯🇵Japan🏠Remote📁Legal & Compliance
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Company Overview A global regulatory and compliance solutions provider, primarily focused on the life sciences and healthcare industries. The company offers a broad range of services, including regulatory affairs, product registration, market access, and other services that help pharmaceutical, biotechnology, medical device, and consumer health companies navigate complex regulatory frameworks and ensure compliance with local and international regulations. Job Description Work with submission managers to prepare high- quality regulatory submissions ( eCTD, NeeS, Paper) that meet internal and external standards. Ensure submissions pass validation checks required by health authorities. Lead, train, and support publishing staff ( both internal and external). ( for Experienced candidates) Help teams prepare content that’s submission- ready and meets deadlines. Identify and manage risks that could affect submission quality or timelines. Monitor and report project progress, daily activities, and publishing issues. Oversee and improve publishing processes, tools, and documentation. Act as a subject matter expert and mentor; collaborate with external partners. Drive process improvements by analyzing current practices and suggesting changes. Requirements Skills Required: At least 6 months onwards of experience in Regulatory publishing. Bachelor’s / Master’s in Pharmacy / Pharma / Medical or other associated scientific discipline Expertise with industry standard electronic document management system Experience with project management and leading teams Benefits - Remote / Work from Home - Good Salary package - 65 years old and beyond for retirement age - Can potentially transition internally into other functions (CMC RA, Development RA, Document specialist etc.) - Grow your career within eCTD Publishing as manager or team leader

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