[Remote] CMC Specialist

• 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