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

[Remote] Regulatory Operations - eCTD Publishing Head

Key Facts

Remote From: 
Full time
Mid-level (2-5 years)
English, Japanese

Other Skills

  • Team Management
  • Collaboration
  • Training And Development
  • Problem Solving

Roles & Responsibilities

  • 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
  • Fluency in both English and Japanese

Requirements:

  • Lead the preparation of regulatory submission packages
  • Ensure documents meet internal standards and regulatory guidelines
  • Train and mentor internal teams and external publishing partners
  • Support submission teams in defining content requirements
  • Monitor project progress and daily publishing tasks
  • Lead the creation and maintenance of publishing procedures

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.


Related jobs

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

We help you get seen. Not ignored.

We help you get seen faster — by the right people.

🚀

Auto-Apply

We apply for you — automatically and instantly.

Save time, skip forms, and stay on top of every opportunity. Because you can't get seen if you're not in the race.

AI Match Feedback

Know your real match before you apply.

Get a detailed AI assessment of your profile against each job posting. Because getting seen starts with passing the filters.

Upgrade to Premium. Apply smarter and get noticed.

Upgrade to Premium

Join thousands of professionals who got noticed and hired faster.