Regulatory Affairs Specialist

Merck Merck · Pharma · Seoul, South Korea

This role is responsible for the registration of new animal health products (biologicals and pharmaceuticals) and managing variations with health authorities, specifically APQA in Korea. It also involves managing local Quality Control (QC) matters with a pharmacist, overseeing the DPOC role, preparing for pharmacy inspections, and handling pharmacovigilance and complaint reporting.

What you'd actually do

  1. Responsible for registration of new products and variation.
  2. Compile and submit registration document according to Animal Health registration procedure and Korean regulation
  3. Compile and submit the variation documents to authority according to request of HQ and Korean regulation
  4. Responsible for National/General QC test process
  5. Responsible for Pharmacovigilance and complaint report as DPOC

Skills

Required

  • Animal Health Care
  • Pharmacovigilance
  • Product Registrations

Nice to have

  • Communication
  • Veterinarian (required)
  • Master's degree (preferred)
  • 5+ years of industry experience (preferred)

What the JD emphasized

  • Korean regulation
  • Pharmacovigilance
  • Animal Health Care