Regulatory Affairs Associate

Hyphens Pharma Philippines, Inc.; Metro Manila; On-site; PHP 600,000 - 800,000; Full time

Job summary

Hyphens Pharma Philippines, Inc. in the Philippines is seeking a Regulatory Affairs Associate to support regional PV and RA activities across ASEAN, ensuring compliance with regulatory standards.

Based in Ortigas Center, Pasig City, you will maintain regulatory dossiers, assist in product registrations, renewals, variations, and support audits while coordinating with regional teams. The role requires a Pharmacy degree, a professional license, 2–3 years PV experience, strong organizational

Qualifications

• Bachelor’s Degree in Pharmacy or equivalent with Professional License.
• 2–3 years of pharmacovigilance experience.
• Willingness to travel across ASEAN countries and based in Ortigas Center, Pasig City.

Responsibilities

• Support regional pharmacovigilance activities, including adverse events, literature screening and QA support.
• Assist regional regulatory affairs tasks: registrations, renewals, variations and dossier maintenance.
• Maintain regulatory dossiers, files, tracking sheets, databases and product labels; monitor progress.

Skills

Regulatory affairs

Pharmacovigilance

Analytical

Detail-oriented

Travel willing

Education

Bachelor's Degree in Pharmacy

Professional License

Job description

About the Role:

We are looking for a Regulatory Affairs Associate to join our team in the Philippines. This role has a dual focus on regional pharmacovigilance (PV) and regulatory affairs (RA) activities across the ASEAN region, ensuring compliance with industry standards and regulatory requirements.

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.