Location: Phra Khanong, Bangkok

Job Description

• Oversee and manage full lifecycle product registration in compliance with legal regulations and timeline requirements.
• Coordinate with the FDA and relevant agencies to prepare, submit, and expedite regulatory dossiers.
• Monitor submission statuses and prepare monthly reports for registration renewals and new license approvals.
• Stay updated on relevant healthcare regulations/laws to provide strategic advice for new product registrations.
• Collaborate with internal teams (Manufacturing, Marketing, Product) to handle factory and product license renewals.
• Maintain a systematic and organized regulatory filing system for efficient document retrieval.

Qualifications

• Bachelor’s degree in Science, Pharmaceutical Sciences, or related field.
• Minimum 1 year of experience in Regulatory Affairs (Medical Devices or Pharmaceuticals).
• Strong analytical, organizational, planning, and problem-solving skills.
• Excellent interpersonal skills with high resilience under pressure.
• Ability to travel to the manufacturing plant in Phanom Sarakham, Chachoengsao (Travel/Gas allowance provided).