Key Facts

Remote From:

Japan

Full time

Mid-level (2-5 years)

English, Japanese

Hard Skills

Regulatory Compliance Project Management Digital File Management Continuous Monitoring Internal Documentation

Other Skills

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Team Management
•
Collaboration
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Training And Development
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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

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

Human Resources, Staffing & Recruiting

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

➡️ HERE IS WHAT WE DO We specialize in searching for and recruiting top talent in the Pharmaceutical and Medical Device Industry in Japan (JPAC) and Asia (APAC) via our Japan and Singapore offices. ➡️ HOW DO WE GET THINGS DONE With nearly two decades of recruitment experience in the Pharmaceutical Industry in Japan and Asia, we have the client-relationship expertise, knowledge, persistence, dedication, and diligence to ensure even the most challenging recruitment searches are successful. ➡️ FOR HIRING MANAGERS Through our extensive contacts with the best, brightest, and most well-prepared candidates in the market, combined with the ability to fully understand our clients' needs, we can quickly provide the perfect solution to your requirements. ➡️ FOR JOB SEEKERS We take the time to listen, understand and present opportunities to you when you are ready. ➡️ WHERE HAVE YOU SEEN US Since 2006, Philip has been writing a monthly column for Pharma Japan. He has also been published in Life Science Leader, The Fordyce Letter and Biosimilar Development. ➡️ WHAT OTHERS SAY "Philip has exceptional knowledge of the Japanese Pharmaceutical Industry. Philip is also dedicated to advancing global business leaders’ knowledge and applied skills through his insightful articles. I have found the articles beneficial in both the business environment and as excellent discussion topics as part of the International Management course I teach at the University of Texas. I highly recommend Philip to support a company's efforts to advance their firm with a "Global Mindset" staff and practices". Scott Manning, Lecturer at San Diego State University and former Country Manager of Alcon Japan "Philip is extremely knowledgeable of the Japanese Pharma Industry and his articles are always very intriguing. He is certainly a person that can identify talent and professionals that could grow and add value to the hiring company" Masaki Nakanishi, Director of Business Development at AnGes, Inc.

Company type: TPE

Industry: Human Resources, Staffing & Recruiting

Founded: 2018

Company size: 11 - 50

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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.