Description
Baxter is hiring for a Taiwan regulatory affairs role focused on drug registration. The position coordinates regulatory strategy, prepares and submits regulatory documents such as NDAs, PMFs, DMFs, license renewals, and variations, maintains regulatory systems, monitors regulatory changes, liaises with regulatory agencies, and collaborates with R&D, QA, PV, manufacturing, business unit, and marketing teams. The role also assesses product labeling, packaging, and advertising for compliance. Expert knowledge of drug regulations, communication, problem-solving, time management, project management, and cross-functional collaboration are required; pharmacists are preferred.
