Japan_Development pharmaceutical affairs
Core
Regulatory affairs and quality assurance work supporting the product lifecycle of biopharmaceuticals, focusing on application submissions and compliance.
Role type
Regulatory Affairs Specialist (Biopharmaceuticals)
Builds
Regulatory submissions and quality assurance protocols for biosimilars and innovative biopharmaceuticals
Domain
Biopharmaceuticals / Regulatory Affairs
Deliverable
client delivery
Required skills
Pharmaceutical application preparation, CTD and FD document creation, regulatory authority liaison, CMC regulatory support, project coordination for new product introductions, manufacturing compliance verification
Preferred skills
Experience in global pharmaceutical markets, knowledge of international regulatory standards
Technologies
CTD, FD
Responsibilities
Prepare and review pharmaceutical applications and change notifications, coordinate internal and external communications for regulatory submissions, participate in new product introduction projects from regulatory and QA perspectives, conduct regulatory consultations, support CMC regulatory activities, negotiate with manufacturers to ensure alignment between approved content and manufacturing methods