Regulatory Affairs Assistant — FDA QPIRA Support

ICare Biotechnology Inc.; Makati; On-site; PHP 268,000 - 301,000; Full time

Job summary

ICare Biotechnology Inc. is seeking an Administrative Assistant – Regulatory Affairs to provide regulatory and administrative support for Medical Device and Cosmetic operations in the Philippines.

The role involves coordinating product registrations, maintaining regulatory docs, preparing PIFs, and supporting LTO and submissions; may serve as FDA QPIRA for Medical Devices and Cosmetics. Applicants should have a life sciences degree, 1–2 years in Regulatory Affairs or FDA compliance, and

Qualifications

• Bachelor's degree in Pharmacy, Chemistry, Medical Technology, Nursing, or related Life Science.
• Preferably a PRC Licensed Professional. (Priority given)
• At least 1–2 years of Regulatory Affairs or FDA compliance experience.
• Knowledgeable in Philippine FDA regulations for Medical Devices and Cosmetics.
• Familiar with LTO, CMDN/CMDR/CPR, CPN, PIF.
• Holder of or willing to obtain FDA QPIRA Certification for Medical Devices and/or Cosmetics.

Responsibilities

• Provide administrative support to Regulatory Affairs and Quality teams.
• Assist in maintaining FDA License to Operate and other regulatory permits.
• Prepare and maintain regulatory documentation for Medical Devices and Cosmetics.
• Prepare and submit FDA applications (CMDN/CMDR/CPR, CPN) and variations/renewals.
• Maintain Product Information Files (PIF) and safety documentation for cosmetics.
• Coordinate with suppliers on regulatory requirements and docs.
• Communicate with Philippine FDA on submissions and inquiries.
• Monitor registration status, renewal schedules, deadlines.
• Keep electronic and physical regulatory files organized.
• Assist during FDA inspections and audits.

Skills

Regulatory affairs

FDA compliance

Microsoft Office

Documentation

Communication

Education

PRC Licensed Professional (preferred)

FDA QPIRA Certification (preferred)

Bachelor's degree in Pharmacy, Chemistry, Medical Technology, Nursing or related Life Science

Tools

Philippine FDA eServices Portal

Job description

ICare Biotechnology Inc. is seeking an Administrative Assistant – Regulatory Affairs to provide regulatory and administrative support for Medical Device and Cosmetic operations in the Philippines.

The role involves coordinating product registrations, maintaining regulatory docs, preparing PIFs, and supporting LTO and submissions; may serve as FDA QPIRA for Medical Devices and Cosmetics. Applicants should have a life sciences degree, 1–2 years in Regulatory Affairs or FDA compliance, and