About the Job
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.
Requirement Skill
Communication
Problem solving
Team work
HEALCARE
How To Apply
Interested and qualified candidates Send your cv on my email [email protected] or through telegram 0944203136
More Information
- Experience Level Junior
- Total Years Experience 0-5
- Qualification BA/BSc
