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 categoriespharmaceuticals, medical devices, cosmetics, and health supplementsto 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.
