Regulatory Affairs Specialist (URGENT HIRING) - Makati City

Job Requirements

• At least 1–2 years of relevant working experience in Regulatory Affairs or a related field.
• With experience in FDA registration and regulatory compliance .
• Preferably with experience in FDA registration for both medical devices and pharmaceutical products .
• Willing to conduct fieldwork as required.
• Detail-oriented, organized, and capable of handling regulatory documents and requirements.
• Good communication and coordination skills.

Responsibilities

• Prepare, process, and monitor FDA registration applications for medical devices and pharmaceutical products.
• Ensure regulatory documents comply with applicable FDA requirements and guidelines.
• Coordinate with the FDA and other relevant regulatory agencies regarding applications, submissions, and compliance matters.
• Monitor application status, renewals, product registrations, and regulatory deadlines.
• Conduct fieldwork related to regulatory submissions, document processing, and agency coordination.
• Maintain accurate and updated regulatory records and documentation.
• Assist in resolving regulatory concerns and ensuring timely completion of registration requirements.