Key Facts

Remote From:

Japan

Full time

English, Japanese

Hard Skills

Regulatory Compliance Risk Analysis Parts Manufacturer Approval

Other Skills

•
Collaboration
•
Communication

Roles & Responsibilities

Proficiency in Japanese
Proficiency in English

Requirements:

Evaluate change controls and develop submission strategies
Identify Japan’s regulatory requirements and assess supporting documentation for compliance and risk
Prepare high-quality variation packages for Partial Change Applications (PCA) and minor change notifications
Draft responses to Requests to Query (RTQs) based on guidance from CMC strategists

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

Evaluate change controls, develop submission strategies, identify Japan’s regulatory requirements, and assess supporting documentation for compliance and risk, while independently executing tasks aligned with Japan regulations and guidance.
Prepare high-quality variation packages for Partial Change Applications (PCA) and minor change notifications.
Draft responses to Requests to Query (RTQs) based on guidance from CMC strategists, ensuring alignment with current Japan requirements.
Provide operational support for preparing GMP inspection packages, including PAI for NDA and PCA/Periodic inspections.
Assist in authoring GMP inspection packages for Foreign Manufacturer Accreditation and PMDA consultations.
Collaborate with clients and external partners to ensure compliant change management execution, maintaining a strong focus on regulatory adherence.