Administrative Assistant – Regulatory Affairs

ICare Biotechnology Inc.

Makati

On-site

PHP 268,000 - 301,000

Full time

14 days+

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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

Administrative Assistant - Regulatory Affairs (FDA Qualified Person in Industry Regulatory Affairs [QPIRA] – Medical Devices & Cosmetics)

The Administrative Assistant – Regulatory Affairs will provide administrative and regulatory support for the Company ' s Medical Device and Cosmetic operations. The position will assist in ensuring compliance with Philippine FDA regulations by coordinating product registrations, maintaining regulatory documentation, preparing Product Information Files (PIF), and supporting License to Operate (LTO) and product registration activities. The successful candidate will also serve as or support the Food and Drug Administration (FDA) Qualified Person in Industry Regulatory Affairs (QPIRA) for Medical Devices and Cosmetics, ensuring compliance with Philippine FDA requirements and applicable ASEAN regulations.

Key Responsibilities

Provide administrative support to the Regulatory Affairs and Quality team.
Assist in maintaining the Company's FDA License to Operate (LTO) and other regulatory permits.
Prepare, organize, and maintain regulatory documentation for Medical Devices and Cosmetics.
Assist in the preparation and submission of FDA applications, including:
- Medical Device Registration (CMDN/CMDR/CPR)
- Cosmetic Product Notifications (CPN)
- Other regulatory applications, variations, renewals, and amendments
Prepare and maintain Product Information Files (PIF) and supporting safety documentation for cosmetic products.
Coordinate with local and international suppliers regarding regulatory requirements and technical documentation.
Communicate and coordinate with the Philippine FDA regarding submissions, compliance, and regulatory inquiries.
Monitor product registration status, renewal schedules, and regulatory deadlines.
Maintain organized electronic and physical regulatory files.
Assist during FDA inspections and ensure regulatory documents are complete and readily available.
Ensure compliance with FDA regulations, DOH requirements, the ASEAN Cosmetic Directive, and applicable Medical Device regulations.
Perform other administrative and regulatory duties assigned by Management.

Qualifications

Bachelor's Degree in Pharmacy, Chemistry, Medical Technology, Nursing, or any related Life Science course.
Preferably a PRC Licensed Professional. (Candidates with a valid PRC license will be given priority.)
At least 1–2 years of experience in Regulatory Affairs, FDA compliance, or related administrative work.
Knowledgeable in Philippine FDA regulations for Medical Devices and Cosmetics.
Familiar with:
- License to Operate (LTO)
- CMDN/CMDR/CPR applications
- Cosmetic Product Notification (CPN)
- Product Information File (PIF)
Holder of or willing to obtain the Food and Drug Administration (FDA) Qualified Person in Industry Regulatory Affairs (QPIRA) Certification for Medical Devices and/or Cosmetics.
Training or experience in Cosmetic Regulations or Cosmetic Product Safety Assessment is an advantage.
Detail-oriented with excellent organizational and documentation skills.
Good written and verbal communication skills.
Proficient in Microsoft Office (Word, Excel, PowerPoint) and PDF document management.

Preferred Qualifications

Certified Food and Drug Administration (FDA) Qualified Person in Industry Regulatory Affairs (QPIRA) for Medical Devices and/or Cosmetics.

Experience using the Philippine FDA eServices Portal.

Experience serving as or assisting the Food and Drug Administration (FDA) Qualified Person in Industry Regulatory Affairs (QPIRA) for Medical Devices and/or Cosmetics.