Regulatory Associate Affair
3 days ago
Qualifications:
· Licensed Pharmacist OR Licensed Nurse (PRC Registered)
· At least 1–2 years of experience in regulatory affairs within the pharmaceutical industry. (But fresh graduates with excellent credentials are welcome to apply)
· Knowledgeable in FDA, DOH, and other applicable regulatory agency guidelines
· Experience in product registration, LTO renewals, and labeling compliance
· Familiar with GMP, GDP, and pharmacovigilance processes
· Strong analytical, organizational, and documentation skills
· Proficient in Microsoft Office applications (Word, Excel, PowerPoint)
· Excellent communication skills and ability to coordinate across departments
Key Responsibilities:
· Prepare, compile, and submit regulatory documents for product registration, amendments, and renewals to FDA and other regulatory bodies
· Monitor and ensure timely renewal of Licenses to Operate (LTO), Certificates of Product Registration (CPR), and other required permits
· Ensure compliance of product labeling, packaging, and promotional materials with local regulatory standards
· Coordinate with Quality Assurance, Marketing, and Supply Chain teams for regulatory-related concerns
· Monitor updates and changes in regulatory requirements and implement necessary compliance adjustments
· Support audits and regulatory inspections by preparing and maintaining accurate regulatory files
· Handle import/export permit applications and product notification processes
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