Regulatory Affairs Associate

Hyphens Pharma International Ltd.; Philippines; On-site; PHP 446,000 - 781,000; Full time

Job summary

Hyphens Pharma International Ltd. is seeking a Regulatory Affairs Associate to join our Philippines team. The role involves supporting Regional Pharmacovigilance (PV) and Regulatory Affairs (RA) activities across ASEAN, with responsibilities spanning safety reporting, QA, dossier management, and regulatory compliance.

Based in Ortigas Center, Pasig City, travel across ASEAN is required. The ideal candidate is a licensed pharmacist with 2-3 years in PV, strong organizational skills, and readiness

Qualifications

• Bachelor's Degree in Pharmacy or equivalent; Professional License required.
• Minimum 2-3 years of experience in pharmacovigilance.
• Highly organized, analytical, and detail-oriented.
• Willingness to travel across ASEAN countries.
• Based in Ortigas Center, Pasig City.

Responsibilities

• Regional Pharmacovigilance: review, update, and maintain PV/GDP documentation; coordinate PV activities; training; QA support; manage quality agreements; assist audits.
• Regional Regulatory Affairs: support product registrations, renewals, variations; maintain regulatory dossiers and labels; monitor registration status; prepare regulatory reports; stay updated on regulatory changes; provide local regulatory support in the Philippines.

Skills

Pharmacovigilance

Regulatory affairs

Attention to detail

Willing to travel

Education

Bachelor's degree in Pharmacy

Professional License

Job description

About the Role

Be part of a growing regional pharmaceutical company with a presence across ASEAN. As we continue to expand our portfolio and operations, we are looking for a Regulatory Affairs Associate to join our team in the Philippines. This role offers the opportunity to work beyond the Philippine market, supporting both Regulatory Affairs (RA) and Pharmacovigilance (PV) activitiesacross multiple ASEAN countries. If you're a licensed pharmacist who enjoys working in a fast-paced regional environment and wants exposure to a broader regulatory landscape, we'd love to hear from you.

Key Responsibilities

1. Regional Pharmacovigilance

• Support the regional team in reviewing, updating, and maintaining the Quality Management System, including GDP and PV documentation across ASEAN.
• Coordinate pharmacovigilance activities, including adverse events and product complaint handling, medical information enquiries, monthly reconciliations, and literature screening.
• Conduct regular training for employees on Good Distribution Practice (GDP), Good Storage Practice (GSP), and Pharmacovigilance (PV) requirements; maintain training records.
• Assist in investigating and correcting quality-related issues (e.g., temperature excursions, product deviations) in collaboration with other departments and principals.
• Provide QA and technical support for quality-related enquiries, when needed.
• Manage quality agreements with partners and suppliers.
• Support internal and external audits related to regulatory compliance, including documentation and communication (e.g., CAPA management).
• Perform other duties as directed by regional PV and management.

2. Regional Regulatory Affairs

• Support the regional regulatory team in product registrations, renewals, variations, and other regulatory matters across ASEAN, including backend support and dossier compilation.
• Maintain regulatory dossiers, files, tracking sheets, databases, and product labels within the regulatory affairs database.
• Monitor the status of registrations and other regulatory applications across the region.
• Prepare regulatory reports on a regular basis.
• Stay updated on regulatory changes and newly issued regulations.
• Provide local regulatory support in the Philippines as needed.

Requirements

• Bachelor's Degree in Pharmacy or equivalent; Professional License (Passed Professional License Examination) required.
• Minimum 2-3 years of experience in pharmacovigilance.
• Highly organized, analytical, and detail-oriented.
• Willingness to travel across ASEAN countries.
• Based in Ortigas Center, Pasig City.

Why Join Us

• Regional ASEAN exposure
• Opportunities to work on both PV and RA functions
• Be part of a growing healthcare and pharmaceutical business
• Collaborate with regional teams and international partners
• Career growth in a dynamic and expanding organization