Government Relations Coordination
FDA and Cosmeceutical Work (Main) • Prepare documents and submit cosmetic/cosmeceutical notifications via the e-Submission system • Apply for and renew manufacturing, import, and distribution licenses within the deadline • Verify ingredient formulas, labels, and advertising claims for legal compliance • Prepare and maintain PIF, COA, SDS, and stability/safety test result documents • Respond to inquiries and amend documents as requested by FDA officers • Prepare for cosmetic GMP inspections (ASEAN GMP / ISO 22716)
Coordination with other Government Agencies • Customs Department: Import-export documents, customs tariff codes, and customs declarations • Department of Business Development (DBD): Register and amend juristic person information, submit financial statements • Department of Intellectual Property (DIP): Register trademarks, patents, and copyrights • Department of Industrial Works (DIW): Factory operation licenses (Ror Ngor 4) and related reports • Revenue Department / Social Security Office / Department of Labour Protection and Welfare: Coordinate documents as assigned • Provincial Public Health Office (PPHO) / Municipality / Subdistrict Administrative Organization (SAO) / BMA: Local licenses, signage, hygiene, and environment • Pollution Control Department / Office of Natural Resources and Environmental Policy and Planning: Environmental documents (if any) • Standard certification bodies such as TISI, Halal, GMP/ISO: Coordinate application and renewal of certificates • Ministry of Commerce / BOI: Coordinate investment promotion and trade licenses (if any)
Regulatory and Support Work • Monitor new announcements, laws, and guidelines, then summarize the impact on the company • Maintain a license registry with an expiration date alert system • Regularly report submission statuses to management • Provide advice to Marketing, R&D, and Production departments regarding legal requirements
Qualifications: Bachelor's degree or higher in Pharmacy, Chemistry, Science, Cosmetic Science, Law, Political Science, Business Administration, or related fields At least 2 years of experience in FDA coordination / Regulatory Affairs (experience in cosmeceuticals or cosmetics will be specially considered) Understanding of the Cosmetic Act B.E. 2558 and related announcements Ability to use the e-Submission system and online systems of government agencies Knowledge of labeling, ingredients, and advertising regulations Proficiency in Microsoft Office and ability to read English documents Good interpersonal skills, detail-oriented, and able to manage time and deadlines Good wit, able to solve immediate problems and negotiate/coordinate with government officials appropriately Possess a driver's license and private vehicle, ready for field visits
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