Regulatory Officer

About the role

Spartan BTY Inc. is looking for a detail-oriented and knowledgeable Regulatory Officer who will be responsible for ensuring that the company's products, documentation, and business processes comply with applicable regulatory requirements, particularly those of the Food and Drug Administration (FDA) and other relevant government agencies. The Regulatory Officer will handle regulatory applications, product documentation, compliance monitoring, renewals, and coordination with regulatory authorities.

Key responsibilities

• Manage and coordinate FDA-related applications, registrations, licenses, permits, and renewals.
• Prepare, review, organize, and maintain regulatory documents and product dossiers.
• Assist in securing and maintaining License to Operate (LTO) and other applicable regulatory approvals.
• Handle product registration and compliance requirements for cosmetics, skincare, and other applicable consumer products.
• Monitor product documentation to ensure compliance with current FDA rules, regulations, and requirements.
• Coordinate with the FDA and other relevant government agencies regarding applications, submissions, clarifications, and regulatory concerns.
• Ensure that required regulatory documents are complete, accurate, updated, and properly filed.
• Monitor regulatory deadlines, expiration dates, renewals, and submission schedules.
• Review product labels, packaging, claims, and supporting documents for regulatory compliance.
• Assist in preparing documents and requirements for FDA inspections, audits, and other regulatory activities.

About you

• Bachelor's degree in a medical, health science, pharmaceutical, or other relevant field.
• Must have an active PRC license in a relevant medical or health-related profession.
• Preferably with 1–2 years of experience in Regulatory Affairs, FDA compliance, product registration, or a related field.
• Experience dealing with the Philippine FDA and other government regulatory agencies is highly preferred.
• Knowledge of FDA requirements for cosmetics, skincare, health-related, or consumer products is an advantage.
• Familiarity with FDA License to Operate (LTO), product registration, Certificate of Product Registration (CPR), notifications, renewals, and other regulatory submissions is preferred.
• Strong knowledge of regulatory documentation, compliance monitoring, and record-keeping.
• Excellent attention to detail and accuracy when reviewing documents and regulatory requirements.
• Strong organizational and time-management skills, particularly in monitoring deadlines and multiple regulatory submissions.
• Proficient in Microsoft Office, particularly Word, Excel, and document management.

Benefits

• Competitive salary of ₱25,000 – ₱30,000 per month
• Full-time employment
• Monday to Friday schedule
• Opportunity to develop further experience in regulatory affairs and FDA compliance
• Other company benefits and incentives

About us

Spartan BTY Inc. is a company operating in the cosmetics, skincare, and consumer products industry, requiring compliance with Food and Drug Administration (FDA) and other relevant government regulatory requirements.