Regulatory Affairs Specialist - Medical Devices/ Pharmaceutical

Our client is a well-known European medical company that specializes in diagnostic solutions and has been established for over 50 years with operations spanned across 5 continents, with a reputation for being at the forefront innovative healthcare solutions. In Thailand, they operate an office, serving as a regional hub of operations for Indochina. Our client is looking for a Regulatory Affairs Specialist to take on the crucial role within their global organization.

The Regulatory Affairs Specialist will maintain the company’s regulatory compliance by performing a range of pre-market and post-market activities, such as submitting product registration applications, managing change notifications, and handling renewals, among other tasks.

• Oversee and maintain the implementation of local and country regulatory requirements in Thailand.
• Maintain and implement regulatory procedures when required.
• Stay updated on regulatory monitoring processes and changes in regulations, while communicating key impacts to stakeholders.
• Handle product registrations, change notifications, and renewals, ensuring submissions are completed on time.
• Manage and maintain product registration licenses and other regulatory permits with the Thai FDA and other relevant authorities.
• Carry out additional regulatory activities as mandated by Thai authorities to maintain the company’s compliance.
• Conduct change impact assessments in accordance with Thai regulations.
• Provide support for internal and external audits as needed.
• Ensure that the products, packaging, and artwork for both current and new products meet regulatory requirements.
• Support regulatory tasks within the ASEAN region as needed.

Qualifications:

• A bachelor’s degree or higher in Pharmaceutical Science or a related field.
• 3 years + of direct experience in regulatory affairs in Thailand, preferably within the pharmaceutical or healthcare industries.
• Strong command of Thai and English (verbal and written).
• Strong understanding of Thai FDA regulations and ASEAN regulatory frameworks.
• Ability to ensure accuracy in documentation, packaging, and product compliance.
• Excellent communication skills with the ability to work with local, regional, and global teams, stakeholders, and authorities.
• Ability to manage multiple tasks, prioritize tasks effectively, and meet deadlines.
• Proficient in assessing regulatory changes and identifying their impacts on business operations.
• Familiarity with internal and external audit processes is a plus.
• Familiarity with MS Office programs.