Key Facts

Remote From:

Japan , Suriname

Full time

Senior (5-10 years)

Hard Skills

Digital File Management Regulatory Compliance Project Management Risk Management Process Improvement

Other Skills

•
Team Leadership
•
Collaboration

Roles & Responsibilities

At least 6 months experience in Regulatory publishing
Bachelor’s / Master’s in Pharmacy / Pharma / Medical or related discipline
Expertise with electronic document management system
Experience with project management and leading teams

Requirements:

Prepare high-quality regulatory submissions
Ensure submissions pass validation checks
Lead, train, and support publishing staff
Help teams prepare submission-ready content
Identify and manage risks affecting quality or timelines
Monitor and report project progress and issues
Oversee and improve publishing processes and documentation
Act as a subject matter expert and mentor
Drive process improvements

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

Work with submission managers to prepare high-quality regulatory submissions (eCTD, NeeS, Paper) that meet internal and external standards.

Ensure submissions pass validation checks required by health authorities.

Lead, train, and support publishing staff (both internal and external). ( for Experienced candidates)

Help teams prepare content that’s submission-ready and meets deadlines.

Identify and manage risks that could affect submission quality or timelines.

Monitor and report project progress, daily activities, and publishing issues.

Oversee and improve publishing processes, tools, and documentation.

Act as a subject matter expert and mentor; collaborate with external partners.

Drive process improvements by analyzing current practices and suggesting changes.

Requirements

Skills Required:

At least 6 months onwards of experience in Regulatory publishing.
Bachelor’s / Master’s in Pharmacy / Pharma / Medical or other associated scientific discipline
Expertise with industry standard electronic document management system
Experience with project management and leading teams