Regulatory Operations - eCTD Publishing Lead

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July 14

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Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC)

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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.

11 - 50 employees

Founded 2011

💊 Pharmaceuticals

⚕️ Healthcare Insurance

🎯 Recruiter

📋 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.