[Remote] Certifications 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 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.