Senior Specialist, Regulatory Affairs

Abbott

Tokyo, Japan
Not specified; not specified; not specified
Not specified
Regulatory submission development
Agency interaction for approval
Product lifecycle regulatory liaison
Abbott is seeking a Senior Specialist in Regulatory Affairs to work in Tokyo, Japan. The ideal candidate will possess expertise in product registration and regulatory compliance, contributing to the approval process and serving as a liaison throughout the product lifecycle

Job Summary

  • The role serves as an experienced professional individual contributor directing the development of product registration submissions and supplements.
  • The incumbent interacts with regulatory agencies to expedite the approval of pending registrations and ensures timely approval of new drugs and devices.
  • This position acts as a regulatory representative advising marketing and research teams on manufacturing changes, labeling, and appropriate regulations.

Matching Summary

Match Score: 75

Abbott is seeking a Senior Specialist in Regulatory Affairs to work in Tokyo, Japan. The ideal candidate will possess expertise in product registration and regulatory compliance, contributing to the approval process and serving as a liaison throughout the product lifecycle.

Salary

Not specified; Not specified; Not specified

Skills & Requirements

Must-have

  • Regulatory submission development
  • Agency interaction for approval
  • Product lifecycle regulatory liaison

Nice-to-have

  • Risk management experience
  • CMC knowledge application
  • Strategic planning participation

Key Requirements

  • Minimum 1 year experience
  • Associates Degree (± 13 years)
  • Subject matter knowledge in Regulatory Affairs

Work Rights

Not specified

Tailored Resume

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