Senior Executive, Regulatory Affairs

Job Category: Executive
Job Type: Full Time
Job Location: Bangi

Job Requirements:

  1. To keep abreast of regulatory information and registration requirements for both local and export countries. 
  2. To prepare full compilation of a pharmaceutical product dossier for local registration and to follow through with subsequent correspondence till registration approval 
  3. Responsible for Bio-equivalence (BE) submission to regulatory authorities, attend to related queries
  4. To prepare compilation of pharmaceutical product dossier for variation submission to NPRA 
  5. To ensure all regulatory directives received from relevant authorities are attended to promptly and executed within the deadline as set by the authorities. 

General Requirements:

  • Bachelor of Pharmacy or equivalent 
  • Minimum 3 years of relevant experience in pharmaceutical industry

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