Regulatory Affairs Associate

About the Role:

We are looking for a Senior 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.

How to Apply:

Interested candidates are invited to submit their CV and cover letter to [Confidential Information].