Senior Specialist, Regulatory Affairs

AbbVie

Tokyo, Japan
Directing product registration submission
Expediting regulatory agency approval
Serving as regulatory liaison
As an experienced professional in Regulatory Affairs, you will direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports

Job Summary

  • As an experienced professional in Regulatory Affairs, you will direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.
  • You will interact with regulatory agencies to expedite the approval of pending registrations and serve as a regulatory liaison throughout the product lifecycle.
  • This role ensures the timely approval of new drugs, biologics, or medical devices and the continued approval of marketed products.

Matching Summary

As an experienced professional in Regulatory Affairs, you will direct the development of product registration submissions, progress reports, supplements, amendments, or periodic experience reports.

Skills & Requirements

Must-have

  • directing product registration submission
  • expediting regulatory agency approval
  • serving as regulatory liaison
  • product plan development and implementation
  • regulatory strategy development
  • risk management in regulatory affairs
  • chemistry manufacturing control (CMC)

Nice-to-have

  • advising development teams
  • advising marketing teams
  • technical labeling expertise
  • regulatory interpretation skills

Key Requirements

  • Minimum 1 year experience
  • Associates Degree (± 13 years)

Work Rights

Not specified

Tailored Resume

Cover Letter