Pharmaceutical Regulatory Affairs (RA) Officer
Biruhtesfa pharma trading PLCAbout This Role
This role places you at the regulatory crossroads of pharmaceutical supply in Ethiopia. As the RA Officer, you are not just a documenter but a strategic bridge between the company, the Ethiopian Food and Drug Authority (EFDA), and global suppliers. It suits a detail-oriented pharmacist or chemist who enjoys compliance work and wants to gain deep expertise in the country's drug approval ecosystem, rather than working in a retail or clinical setting.
What the Requirements Say About This Role
The job calls for a professional who can navigate both technical documentation and fast-moving logistics. The emphasis on CTD-format dossiers and EFDA guidelines implies you need strong knowledge of international regulatory standards (ICH) adapted to local contexts. Beyond a pharmacy or chemistry degree, the employer is likely seeking someone who can interpret complex regulations and communicate them clearly to procurement and customs teams under tight deadlines.
How to Approach This Application
In your cover letter or interview, highlight any direct experience with dossier preparation or EFDA submissions, even from internships or academic projects. Emphasize your ability to track multiple deadlines and adapt to regulatory changes—mention a specific example where you managed a compliance calendar or resolved a documentation issue. Since this is a junior role, showing eagerness to learn the full regulatory lifecycle (from registration to post-approval monitoring) will set you apart.
Who This Role Suits
This role is ideal for a recent pharmacy or chemistry graduate with 1–3 years of experience who is methodical, communicative, and interested in the administrative side of healthcare. It is moderately competitive, as regulatory affairs is a niche but growing field in Ethiopia’s pharmaceutical sector.
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
Qualifications
- BSc in Pharmacy (B.Pharm)
Experience
Minimum of 2 years’ experience in registering medicines and medical devices is a must.
How To Apply
Interested and qualified candidates Send your cv on my email [email protected] or through telegram 0944203136
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Pharmaceutical Regulatory Affairs (RA) Officer
Biruhtesfa pharma trading PLC
