(Sr.) Regulatory Affairs Specialist

AstraZeneca

📍 Taiwan, Taiwan, Taiwan 💼 Full time 🕒 Posted February 23, 2026

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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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Job Details

Location Taiwan, Taiwan
Job Type Full time
Category Business Operations Specialists
Posted Date February 23, 2026
Application Deadline April 04, 2026