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Regulatory Affairs Manager

Company

Real Staffing

Location

Japan, Japan

Type

Permanent


About the Company


The Opportunity


We are seeking an experienced Regulatory Affairs Manager to join a dynamic and collaborative regulatory team. This is a key role responsible for driving regulatory strategy and ensuring successful product registrations and lifecycle management across multiple markets.


This position offers the opportunity to work on high-impact products across Vaccines, Oncology, Rare Diseases, and Specialty Care-experience in these therapeutic areas will be highly advantageous.


Key Responsibilities



  • Develop and implement regional and global regulatory strategies to support product development and commercialization

  • Lead regulatory submissions (CTA/IND/NDA/BLA/MAA) and manage interactions with health authorities

  • Ensure timely approvals and compliance with local and international regulation...

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