[Remote] Regulatory Operations - eCTD Publishing Head

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 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.