Regulatory Affairs Director

• 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.