 
						Regulatory Affairs Officer
9 hours ago
Key Responsibilities:
1. Product Registration and Compliance
- Prepare, submit, and monitor applications for product registration, renewal, and amendments with the Food and Drug Administration (FDA) and other relevant agencies.
- Maintain an updated tracker of all regulatory documents, permits, and certificates.
- Ensure product labels, packaging, and claims are compliant with current regulations.
2. Intellectual Property (IPO) Management
- Handle filing, renewal, and maintenance of trademark and intellectual property registrations with the Intellectual Property Office (IPO).
- Coordinate with external legal counsel or agencies for IP-related matters.
- Monitor and safeguard the company's brand and trademark portfolio.
3. Importation and Customs Compliance
- Prepare and secure necessary permits, clearances, and certifications for product importation.
- Coordinate with the Bureau of Customs (BOC), brokers, and suppliers for import documentation and release of shipments.
- Ensure all imported goods comply with labeling and regulatory requirements prior to distribution.
4. Documentation and Reporting
- Maintain a comprehensive and organized regulatory database and filing system.
- Prepare periodic reports on regulatory submissions, status updates, and compliance metrics.
- Support audits and inspections conducted by government agencies.
5. Cross-Functional Coordination
- Work closely with Supply Chain, Marketing, Quality Assurance, and Legal teams to ensure regulatory alignment in product lifecycle management.
- Provide regulatory guidance in product development, packaging design, and advertising materials.
- Bachelor's degree in Pharmacy, Chemistry, Biology, or any related course.
- At least 1–2 years of experience in Regulatory Affairs or related field.
- Knowledge of FDA regulations, IPO processes, and Customs procedures.
- Strong attention to detail, analytical, and organizational skills.
- Excellent communication and coordination abilities.
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