Regulatory Affairs Associate

Unilab, Inc.


Date: 2 days ago
City: Mandaluyong City
Contract type: Full time

Role Overview:

  • Communicates registration requirements to Enablers
  • Handles Food and Drug Administration's registration documents                 
  • Refers to the checklist needed to comply for submission                
  • Evaluates and assesses the completeness and correctness of documents            
  • Submits and monitors status updates of submitted documents
  • Manages product registration and renewal of existing products
  • Files Amendments/Variations with the Food and Drug Administration
  • Prepares monthly operations reports and other assigned tasks 


Required Qualifications:

  • Graduate of Bachelor of Science in Pharmacy, and must be a licensed Pharmacist
  • With 1-2 years experience in Regulatory and/or Medical Affairs
  • Knowledgeable in FDA guidelines and medical information
  • Must have good interpersonal skills and able to work well independently
  • Attention to detail, ability to multi-task and meet strict deadlines

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