RA TA Group, Regulatory Affairs(Oncology)

Added
1 hour ago
Type
Full time
Salary
Salary not provided

Related skills

documentation regulatory affairs regulatory compliance regulatory strategies new drug applications
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๐Ÿ“‹ Description

  • execute regulatory affairs activities for assigned projects
  • prepare and submit regulatory documents
  • collaborate with cross-functional project teams
  • lead and implement regulatory strategies
  • interact with pmda/mhlw and internal stakeholders
  • monitor and interpret regulatory changes

๐ŸŽฏ Requirements

  • regulatory affairs
  • new drug applications
  • pmda consultations
  • clinical trial notifications
  • package inserts
  • regulatory strategies
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