Regulatory Affairs Specialist – Licensed Pharmacist

Global Quest Consulting Group

Hinatuan

On-site

PHP 420,000 - 640,000

Full time

24 hours ago

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Job summary

Global Quest Consulting Group is seeking a Regulatory Affairs Pharmacist to ensure compliance of company products and processes with local and international requirements. You will monitor regulatory changes, prepare dossiers, and support audits and inspections.

The role requires a licensed pharmacist with 1–2 years in regulatory affairs or FDA registration, strong document control, and excellent communication and leadership skills. Based in Greenhills, San Juan City, Metro Manila.

Qualifications

Licensed Pharmacist with strong regulatory knowledge.
1–2 years of regulatory affairs or FDA registration experience preferred.

Responsibilities

Ensure company products and processes comply with applicable laws, regulations, standards, and guidelines.
Monitor changes in regulatory and compliance requirements and assess their impact on existing and new products.
Support internal audits, regulatory inspections, and compliance reviews.
Maintain proper document control systems, SOPs, and compliance records.
Prepare, compile, review, and maintain regulatory dossiers in compliance with local and international regulatory requirements.
Manage product registration, renewal, variation, and amendment submissions with relevant regulatory authorities.