JOB DETAILS

JOB DETAIL

Product Registration and Licensing:
o Manage and execute the registration of product licenses and other regulatory approvals
with the Thai FDA and other relevant authorities for both imported and exported products.
o Conduct thorough analysis and evaluation of new product requirements, including formula
checks and reviewing registration documents, identifying and addressing any gaps or
deficiencies.
Regulatory Compliance:
o Prepare and approve product labels, packaging, and artwork to ensure compliance with
Thai regulatory standards.
o Prepare and maintain the Cosmetic Product Information File (PIF) and other necessary
regulatory documentation.
Documentation and Reporting:
o Handle all documentation related to FDA submissions and maintain up-to-date registration
records.
o Provide regular updates to the business on the status of product registrations and
regulatory compliance.
Regulatory Advisory:
o Provide expert regulatory advice to internal teams, including research and development,
sales, and marketing, addressing inquiries and ensuring alignment with regulatory
requirements.
o Stay informed about current regulations and standards, and proactively identify trends that
may impact the business.
Regulatory Knowledge Maintenance:
o Continuously update and expand knowledge of applicable regulations, industry standards,
and best practices to ensure compliance and provide accurate guidance to the business.
Import Management:
o Coordinate and manage import processes, ensuring all products meet regulatory and
customs requirements.
o Liaise with relevant authorities to ensure smooth importation and clearance of products.
Other Duties:
o Perform any other regulatory-related tasks as assigned to support the business.

REQUIRED WORK EXPERIENCE

o Bachelor’s degree in Pharmacy, Chemistry, or a related field.
o 3-5 years of experience in regulatory aƯairs, preferably in the cosmetics, pharmaceuticals,
or healthcare industry.
o In-depth knowledge of Thai FDA regulations and product registration processes.
o Strong analytical skills with the ability to evaluate and address regulatory requirements.
o Excellent communication skills, both written and verbal.
o Ability to work independently and manage multiple tasks simultaneously.
o Proficiency in Thai and English languages.