Regulatory Affairs Specialist

작업 내용

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.
  
  

Major Responsibilities

To obtain and maintain regulatory approval of product registration in Taiwan and work according to Good Regulatory Practice (GRP)

• 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 Electronic Library (ANGEL)
• To submit the registration application in accordance with the agreed filing strategies and planning
• To ensure regulatory activities comply with the company’s SOPs and meet GRP
  
  

To liaise with Emerging Market Regulatory Affairs (EMRA) and local Regulatory Authorities to ensure full regulatory compliance of the company

• To deliver local regulations to EMRA timely
• To develop competency to meet AstraZeneca standards
  
  

Qualification

• University education in bio/medical or pharmacy area
• Good command in English
• Background in pharmacy related field