Regulatory Affairs Specialist

Merck Merck · Pharma · Ho Chi Minh, Vietnam

This role is responsible for regulatory affairs in Vietnam, ensuring compliance with local regulations for company products. Key activities include preparing and submitting documentation to regulatory agencies, monitoring regulations, reviewing labeling, and acting as a pharmacovigilance contact.

What you'd actually do

  1. Prepares and oversees documentation packages for submission to Vietnamese regulatory agencies; tracks timelines and key milestones to ensure timely submissions; liaise with regulatory agencies during the review process.
  2. Monitors proposed and current Vietnamese regulations and guidance and assess their impact on company products and activities.
  3. Review product labeling and promotional materials to ensure compliance with applicable regulation.
  4. Prepare Vietnamese labels in accordance with local regulations.
  5. Act as Pharmacovigilance contact point for Vietnam

Skills

Required

  • Regulatory Affairs Compliance
  • Regulatory Compliance
  • Regulatory Affairs Management
  • Regulatory Submissions
  • Regulatory Reporting
  • Regulatory Communications
  • Regulatory Project Management
  • Regulatory Strategy Development
  • Regulatory Experience
  • Regulatory Inspections
  • Pharmaceutical Regulatory Affairs
  • Pharmacovigilance
  • Electronic Common Technical Document (eCTD)
  • Cross-Team Coordination
  • Pressure Management
  • Detail-Oriented
  • Technical Writing
  • Biological Sciences
  • Biotechnology
  • Animal Husbandry
  • Immunochemistry
  • Microbiology
  • Employee Training Programs
  • Adaptability