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 Any gender.
o Bachelor’s degree in Pharmacy, Chemistry, or a related field.
o 1-5 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 Good command in English languages.