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[Remote] CMC Specialist

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Full Remote
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Offer summary

Qualifications:

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.

Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) logo
Morunda | Pharmaceutical | Medical Device Recruiting | Japan (JPAC) Asia (APAC) Human Resources, Staffing & Recruiting TPE https://www.morunda.com/
11 - 50 Employees
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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.



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.

Other Skills

  • Collaboration
  • Communication

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