Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)
Pharmaceuticals • Healthcare Insurance • Recruitment
Morunda is a recruitment firm specializing in connecting multinational companies within the pharmaceutical and medical device industries with top talent in Japan and Asia-Pacific. With over 75 years of combined experience, Morunda focuses on placing senior-level professionals and aiding in market entry strategies, ensuring that organizations find the right candidates to drive success in the healthcare sector.
Regulatory Operations – eCTD Publishing Head
Job not on LinkedIn
July 14
🗣️🇯🇵 Japanese Required
Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)
Pharmaceuticals • Healthcare Insurance • Recruitment
Morunda is a recruitment firm specializing in connecting multinational companies within the pharmaceutical and medical device industries with top talent in Japan and Asia-Pacific. With over 75 years of combined experience, Morunda focuses on placing senior-level professionals and aiding in market entry strategies, ensuring that organizations find the right candidates to drive success in the healthcare sector.
📋 Description
• Collaborate closely with submission managers to lead the preparation of high-quality regulatory submission packages (eCTD, NeeS, or paper), ensuring all documents meet internal standards and regulatory guidelines. Guarantee that submission packages meet the necessary technical standards for validation by health authorities. Take a leadership role in training and mentoring both internal teams and external publishing partners. Support submission teams in defining content requirements and aligning timelines to ensure accurate and timely submissions. Proactively identify and resolve or escalate any risks or issues that may hinder successful submission completion. Monitor project progress, daily publishing tasks, and address any irregularities, contributing to departmental metrics tracking. Provide general administrative support as needed. Lead the creation and maintenance of publishing procedures and documentation, including user acceptance testing for new or updated tools, and delegate tasks as appropriate. Serve as a subject matter expert for specific processes or functions, offering guidance and support to team members and external partners. Analyze workflows and business practices, identify opportunities for improvement, and drive implementation of enhanced processes.
🎯 Requirements
• At least 4 years of hands-on experience in regulatory publishing. Proficient in Lorenz docuBridge, Liquent InSight Publisher, and global publishing systems is a Plus Skilled in using electronic document management systems commonly used in the industry. Demonstrated experience in project leadership and team coordination. Fluency in both English and Japanese is required.
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