Regulatory Affairs Manager

6 days ago

Bangkok, Bangkok, Thailand Hyphens Pharma International Ltd. Full time

Join an
ASEAN-based healthcare leader
as a
Regulatory Affairs Manager
to lead regulatory compliance and quality initiatives in Thailand. This role combines
regulatory strategy
,
Quality Management System (QMS)
oversight, and
Pharmacovigilance (PV)
activities across multiple product categories—
pharmaceuticals, medical devices, cosmetics, and health supplements
—to ensure patient safety and operational excellence.

Key Responsibilities:

  • Manage
    Regulatory Submissions
    for new products, variations, and renewals across all categories (drugs, medical devices, cosmetics, health supplements).
  • Ensure compliance with Thai FDA regulations and ASEAN guidelines.
  • Maintain and improve the local
    Quality Management System
    , ensuring alignment with global standards.
  • Oversee
    Pharmacovigilance
    activities, including adverse event reporting and safety monitoring.
  • Liaise with health authorities and industry associations.
  • Provide regulatory and quality guidance to internal teams.
  • Monitor regulatory and quality-related changes and assess impact on business operations.

Qualifications:

  • Bachelor's degree in Pharmacy, Life Sciences, or related field.
  • Minimum 5 years of experience in Regulatory Affairs, with exposure to QMS and PV.
  • Strong knowledge of Thai FDA regulations and ASEAN guidelines.
  • Excellent communication and stakeholder management skills.
  • Proficiency in English and Thai (written and spoken).

Why Join Us?

  • Lead regulatory, quality, and safety initiatives in a
    strategic ASEAN market
    .
  • Be part of a regional organization with global reach, committed to innovation and patient safety.
  • Collaborative and inclusive work environment.

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