Proficiency in both Japanese and English languages is essential., Experience in regulatory compliance and change management in the pharmaceutical industry is preferred., Strong understanding of Japan's regulatory requirements and guidance is necessary., Ability to prepare high-quality documentation and respond to regulatory queries..
Key responsabilities:
Evaluate change controls and develop submission strategies for compliance with Japan's regulations.
Prepare variation packages for Partial Change Applications and minor change notifications.
Draft responses to regulatory queries based on guidance from CMC strategists.
Collaborate with clients and external partners to ensure compliant change management execution.
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Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) Human Resources, Staffing & Recruiting TPEhttps://www.morunda.com/
11 - 50
Employees
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.
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.
Requirements
Proficiency in both Japanese and English language
Required profile
Experience
Industry :
Human Resources, Staffing & Recruiting
Spoken language(s):
JapaneseEnglish
Check out the description to know which languages are mandatory.