[Remote] CMC Specialist

Company Overview A global regulatory and compliance solutions provider, primarily focused on the life sciences and healthcare industries. The company offers a broad range of services, including regulatory affairs, product registration, market access, and other services that help pharmaceutical, biotechnology, medical device, and consumer health companies navigate complex regulatory frameworks and ensure compliance with local and international regulations. 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