Regulatory Pharmacist – FDA Dossier & Compliance Lead

Euro Generics International Phils. Inc.; Makati; On-site; PHP 600,000 - 900,000; Full time

Job summary

Euro Generics International Phils. Inc. seeks a licensed Pharmacist with regulatory affairs experience to support FDA submissions, renewals, and compliance across importation, distribution, and manufacturing contexts.

The role involves reviewing dossiers, ensuring labeling compliance, coordinating with FDA and suppliers, and maintaining thorough documentation for quality assurance and regulatory tracking.

Qualifications

• Bachelor's degree in pharmacy and active Pharmacist license.
• 3–5 years of regulatory affairs experience in importation, distribution or manufacturing.
• Experience in the pharmaceutical industry.
• Knowledgeable about FDA regulations.

Responsibilities

• Support regulatory activities: review new dossiers for Initial Registration and CPR renewals; handle variations and FDA submissions.
• Prepare and facilitate renewal applications for licenses and foreign GMP compliances.
• Review product dossiers and labeling/packaging to ensure FDA guideline compliance.

Skills

Regulatory affairs knowledge

Attention to detail

English proficiency

Education

Bachelor's degree in Pharmacy

Job description

Euro Generics International Phils. Inc. seeks a licensed Pharmacist with regulatory affairs experience to support FDA submissions, renewals, and compliance across importation, distribution, and manufacturing contexts.

The role involves reviewing dossiers, ensuring labeling compliance, coordinating with FDA and suppliers, and maintaining thorough documentation for quality assurance and regulatory tracking.