Job Description

Core Accountabilities

  • To obtain and maintain regulatory approval of product registration in Taiwan and work according to Good Regulatory Practice (GRP).
  • To liaise with Emerging Market Regulatory Affairs (EMRA) and local Regulatory Authorities to ensure full regulatory compliance of the company.
  • Develop and maintain effective working relationships with internal/external stakeholders to ensure achievement of best possible regulatory outcomes and meet business expectations.

    • Major Responsibilities

  • To prepare all necessary documents to obtain regulatory approvals of Market Authorization in a timely manner.
  • To maintain existing licenses (including license renewal, manufacturing site renewal, API GMP, CMC variations and prescribing text maintenance, etc.)
  • To respond to Regulatory Authority’s questions within required timeline
  • To upload all local regulatory documents and correspondence in AZ Global Elec...

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