Offer summary

Qualifications:

Bachelor's or Master’s degree in science or a related discipline., 2–5 years of relevant experience in regulatory submissions., Strong subject matter expertise in GMP and PMDA processes., Proven ability to convey information effectively, both orally and in writing..

Key responsabilities:

Handle the application process for CPP and GMP compliance inspection requests to PMDA.

Coordinate with stakeholders and CMO sites for timely acquisition of GMP certificates.

Oversee the submission of manufacturing license applications to PMDA.

Prepare and maintain a periodic dashboard for performance communication.

➡️ 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.

Job description

Key Responsibilities:

Handle the application process for CPP and GMP compliance inspection requests to PMDA, including GMP applications if necessary.
Coordinate with relevant stakeholders and CMO sites to ensure timely acquisition of GMP certificates.
Manage the GMP application process to PMDA and GMP compliance inspection requests when needed.
Collaborate with stakeholders and CMO sites to secure the Manufacturing License (ML) certificate.
Oversee the submission of manufacturing license applications to PMDA.
Coordinate with client's entities to obtain necessary letters (LOA/statements), declarations, content confirmations, and facilitate processes for notarization, legalization, or apostille if required.
Receive request orders through the PSS Certificate tool.
Collect certificates from CMO sites or PMDA and forward them to the requester.
Prepare and maintain a periodic dashboard for performance communication.

Requirements

Experience and Skills:

Proven ability to convey information effectively, both orally and in writing, with clarity and logical structure.
Strong subject matter expertise.
Solid understanding of statutory documentation requirements.
Hands-on experience managing submissions and applications to Japan's PMDA for COPP, GMP, and ML.
Bachelor's or Master’s degree in science or a related discipline, with 2–5 years of relevant experience.