Key Facts

Remote From:

Full time

English

Hard Skills

Regulatory Compliance Change Management Regulatory Compliance Change Management Executive Relationship Management Risk Analysis Technical Writing Digital File Management Evaluation Strategy Stakeholder Communications

Other Skills

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Collaboration
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Communication
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Detail Oriented

Roles & Responsibilities

Expertise in Japan regulatory framework, interpretation of regulations and guidance, and ability to develop submission strategies.
Proven experience authoring high-quality variation packages (PCA) and minor change notifications.
Experience supporting GMP inspections and PMDA consultations, including NDA/PCA/Periodic submissions and Foreign Manufacturer Accreditation.
Strong independent work capability and effective liaison with clients and external partners to ensure regulatory conformance.

Requirements:

Assess change controls for assigned products, identify Japan regulatory requirements, evaluate supporting documentation for acceptability and risk, and execute tasks independently per Japan regulations.
Author high-quality variation packages for PCA and minor change notifications, and prepare RTQ responses per CMC strategist guidance and current Japan requirements.
Provide operational support for authoring GMP inspection packages (PAI for NDA and PCA/Periodic) and PMDA Foreign Manufacturer Accreditation consultations.
Liaise with clients and external partners to support compliant change management and maintain regulatory conformance.

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

Responsible for assessment of change controls, preparation of submission strategies, identifying Japan regulatory requirements, and critically evaluating supporting documentation to assess acceptability and identify potential risks for assigned products and the ability to execute tasks independently in accordance with Japan regulations, guidance and discuss regulatory strategies to perform in scope activities.
Authoring of high-quality variation packages for "partial change application (PCA)” and minor change notification.
Authoring response to RTQ (request to query)'s based on the guidance from the CMC strategist in-line with current Japan requirements.
Operational support for Authoring of packages for GMP inspection [PAI for NDA and PCA/Periodic]
Operational support for Authoring of packages for GMP inspection - Foreign Manufacturer Accreditation for PMDA consultation.
Liaise with client and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.