Regulatory Affairs Officer 86 views

LonAdd HR Consultancy Plc (www.lonadd.com) is a Recruitment & Outsourcing Company based in Addis Abeba, Ethiopia, with branch offices in Dukem, Hawassa and Bahir Dar. We are looking to recruit Regulatory Affairs Officer to join On Behalf of Our Client.

Job Location: Addis Ababa

Number required:- 1 (One)

Job Purpose

The Regulatory Affairs Officer (AM04) ensures all DKT Ethiopia pharmaceutical, medical, and health products fully comply with Ethiopian Food and Drug Authority (EFDA) regulations and international quality standards. The role supports the full lifecycle of regulatory compliance from product registration, import authorization, pre-shipment approvals, warehouse GWP/GDP compliance, quality management (I2R SAP), brand/trademark registration, to distribution documentation.

This position is central to safeguarding DKT’s reputation for regulatory integrity, high-quality reproductive health commodities, ethical compliance, and operational excellence.

2. Key Roles and Responsibilities (Expanded & Ethiopia-Specific)

A. Product Registration, Renewal and Dossier Management

• Prepare complete CTD-format dossiers for new product registration with EFDA for:
  Pharmaceuticals
  Medical devices
  Contraceptives
  Diagnostics & commodities
• Maintain registration calendars for renewals, variations, and post-approval changes.
• Ensure all submitted dossiers meet EFDA’s latest guidelines, directives, and circular updates.
• Manage communication with EFDA reviewers and ensure timely responses to comments and deficiencies.
• Prepare technical summaries, comparisons, stability data reviews, batch release documents, and labelling information.

B. Import Permit and Pre-Import Regulatory Compliance

• Prepare, submit, and follow up Import Permit (IP) requests to EFDA, ensuring all required documents are complete:
  • GMP certificate
  • COA, COI, CPP, Free Sale Certificate
  • Product quality specifications
  • Proforma Invoice
  • MSDS (where applicable)
• Work closely with Procurement, Suppliers, and Customs Brokers to align shipment timelines with regulatory approvals.
• Track and follow pre-shipment inspection or testing requirements (if mandated by EFDA).
• Ensure batch-level documentation meets EFDA pre-import criteria.

C. EFDA Compliance for Warehouse GWP/GDP

Ensure ongoing compliance of DKT’s Central Warehouse with EFDA standards:

Warehouse Requirements

• Monitor temperature/humidity logs, calibration records, storage zones, palletization, and ventilation.
• Ensure proper quarantine, rejected, damaged, near-expiry and blocked stock management.
• Review storage of hormonal contraceptives, injectables, implants, and temperature-sensitive products.

Documentation Requirements

• Supervise: Bin cards, Stock cards, Delivery notes and Batch traceability logs
• Ensure all warehouse documentation complies with EFDA audit expectations.

Audit and Inspection Readiness

• Prepare the warehouse for EFDA inspections (announced & unannounced).
• Ensure corrective actions from audits are properly documented and closed.

D. Distribution and Sales Regulatory Oversight

• Verify EFDA-required documents during dispatch:
  • DN with batch and expiry
  • Issue note
  • Product certificates (if required)
• Ensure proper record keeping for distribution of pharmaceuticals.
• Review stock movement reports to ensure traceability across all regions.
• Ensure compliance when distributing SRH products to clinics, pharmacies, NGOs, and implementing partners.

E. SAP Quality Module (I2R – Inspect to Release) Support

The Regulatory Officer plays a role in the quality and release processes inside SAP, specifically:

• Ensure timely documentation of:
  ✔ Quality inspection results
  ✔ Batch release approvals
  ✔ Compliance certificates
  ✔ Regulatory flags or batch blocks
• Validate GRN/GRV documentation for regulatory completeness before I2R release.
• Support Quality Manager in SAP quality event logging (complaints, deviations).
• Maintain up-to-date quality attributes for each approved product in SAP.
• Ensure all released products in SAP match EFDA approval status and batch release requirements.

F. Post-Marketing Surveillance (PMS) and Quality Assurance

• Track and report product quality issues, field complaints, and adverse events.
• Coordinate PMS sampling with EFDA and collaborate during investigations.
• Maintain CAPA documentation for any quality or regulatory deviations.
• Assist in recall procedures, ensuring full documentation and regulatory reporting.

G. Branding, Labelling and Intellectual Property (EIPA)

• Submit trademark and branding registration requests to EIPA for new product names, logos, and packaging artwork.
• Ensure EFDA-compliant labelling:
  Proper strength
  Storage conditions
  Batch/LOT clarity
  Warning statements
  Language requirements
• Coordinate artwork updates with global DKT teams and vendors.
• Maintain all IP certificates, renewal calendars, and branding documents.

H. Internal Compliance, Quality Culture & DKT Values

• Uphold DKT’s culture of accountability, operational integrity, customer impact, and efficiency.
• Promote ethical compliance with regulatory expectations and internal SOPs.
• Provide staff training on regulatory requirements, documentation standards, and EFDA changes.
• Ensure all regulatory actions support DKT’s mission to provide safe, affordable reproductive health products in Ethiopia.

3. Required Qualifications

• B. Pharm (Pharmacist) — Mandatory.
• Valid EFDA Professional License — Mandatory.
• Minimum 3 years’ Pharmacy experience out of it at least 1 years handed experience on Regulatory Affairs, Quality, or Pharmaceutical Compliance.
• Experience preparing CTD dossiers and regulatory submissions.
• Knowledge of EFDA portals:
  • IP application
  • Product registration portal
  • PMS & reporting
• Experience with EIPA trademark registration (advantage).
• Experience with SAP modules (especially I2R Quality, Material Master regulatory attributes, and Inspection Lots).

4. Essential Competencies

Technical Competencies

• Deep understanding of EFDA regulatory systems
• Knowledge of GDP/GWP/GMP
• Familiarity with EFDA inspection processes
• Ability to coordinate with procurement, warehouse, sales
• Understanding of SAP I2R processes
• Strong dossier compilation and documentation skills

Soft and Behavioral Skills

• Excellent written communication (letters, dossiers, regulatory responses)
• Professional maturity and ethics
• Detail-oriented and rule-driven
• Strong follow-up and organizational skills
• Ability to liaise effectively with EFDA and EIPA officials
• Teamwork, humility, and readiness to support internal departments