Pharmaceutical Regulatory Affairs (RA) Officer

Job Description

Biruhtesfa Pharma Trading PLC

Vacancy Announcement

Position:-Pharmaceutical Regulatory Affairs (RA) Officer

Job Summary

The Regulatory Affairs (RA) Officer serves as the primary liaison between the organization and the Ethiopian Food and Drug Authority (EFDA).. The role oversees product registration, license renewals, import permits, and regulatory compliance throughout the supply chain.

Key Responsibilities

Prepare and submit complete CTD-format dossiers
Maintain registration calendar for renewals, variations, and post-approval changes
Ensure all submitted dossiers meet EFDA’s latest guidelines and directives
Coordinate with Procurement, Suppliers, and Customs Brokers to align shipment timelines with regulatory approvals
Monitor regulatory changes and assess impact on existing and new products
Maintain organized records of all regulatory activities, registrations, and imports
Coordinate responses to deficiency letters, regulatory questions, and inspection findings
Represent the company during regulatory inspections and audits
Salary:- Negotiable
About You
Qualifications

BSc in Pharmacy (B.Pharm)
Experience

Minimum of 2 years’ experience in registering medicines and medical devices is a must.