Regulatory Affairs Specialist

ISL PHILS (International Students Link; Makati; On-site; PHP 420,000 - 600,000; Full time

Job summary

ISL PHILS (International Students Link) in Makati seeks a results-driven Regulatory Affairs Specialist to lead FDA registrations for medical devices and pharmaceuticals, with field work as a core component.

You will liaise with regulatory bodies, ensure compliance with local health regulations, and drive timely submissions across product categories. The role requires hands-on experience, attention to detail, and the ability to coordinate across teams in a fast-paced environment.

Qualifications

• 1–2 years of experience in regulatory affairs.
• Experience with FDA registration for medical devices and pharmaceuticals.
• Willingness to perform field work as required.

Responsibilities

• Handle end-to-end FDA registration for medical devices and pharmaceutical products.
• Conduct field work and liaise with regulatory bodies and stakeholders.
• Ensure compliance with local health regulations and standards.

Skills

Regulatory affairs

FDA registration

Field work

Job description

Location: Makati City (Field Work Required)

We are actively seeking a results-driven Regulatory Affairs Specialist to join our team in Makati. If you have hands-on experience handling FDA registrations for medical devices and pharmaceuticals, we want to hear from you!

Key Responsibilities

• Handle end-to-end FDA registration processes for both medical devices and pharmaceutical products.
• Conduct field work and liaise directly with regulatory bodies and relevant stakeholders.
• Ensure company compliance with local health regulations and standards.

Qualifications & Requirements

• Experience: At least 1 to 2 years of working experience in regulatory affairs or a related field.
• FDA Expertise: Proven background in FDA registration (experience in both medical devices and pharmaceuticals is highly preferred).
• Flexibility: Willingness to perform field work as required by the role.