Job description
Oversee and maintain Manufacturing and Marketing Authorizations (MAH) for both pharmaceuticals and medical devices, ensuring full regulatory compliance. Lead regulatory activities related to applications and submissions to relevant agencies (PCA/MCN) for pharmaceuticals and medical devices. Develop and implement strategies to ensure company production activities comply with applicable government regulations.
Track regulatory, guideline, and industry standard updates, assess potential impact, and communicate relevant information across the organization. Conduct periodic GMP/QMS compliance applications, monitor renewal timelines for Foreign Manufacturer Accreditation (FMA/FMR), and secure updated certificates. Plan and manage the RA budget and allocate necessary resources (including external partners) in collaboration with Finance.
Build and maintain strong relationships with key authorities (MHLW, PMDA, Tokyo Metropolitan Government, etc.) and participate in the Committee on Pharmaceutical Affairs. Act as the Japan RA representative, collaborating with the global RA (Corporate) team. Provide internal training and education on pharmaceutical and medical device regulatory processes, best practices, and compliance obligations.
Partner with cross-functional teams (Finance, Safety, Marketing, Supply Chain, Business Units, etc.) to ensure coordination on regulatory matters. Assess applicable regulatory requirements for new product development. Manage RA submission data in internal corporate systems. Define appropriate regulatory strategies to support product development and market approval.
Review submission materials to ensure accuracy, completeness, timeliness, and compliance with regulatory standards. Interpret all components of regulatory submissions (IND, CTA, NDA, etc.) for consistency across documents. Ensure technical, nonclinical, and clinical data are presented clearly and concisely in dossiers to facilitate regulatory review.
Coordinate preparation of responses to health authority questions and requests.
Requirements
Experience with J-NDA submissions, including CTD preparation and direct communication with authorities. Knowledge and experience in QMS surveillance.