Pharmaceutical Regulatory Affairs Officer

• Listing summary: Cheerful Trading PLC, an Ethiopian import‑export firm, is seeking a qualified Pharmaceutical Regulatory Affairs Officer to manage product registrations and imports in compliance with Ethiopian Food and Drug Authority (EFDA) regulations. The role requires a Bachelor of Pharmacy, at least two years’ experience in Ethiopian pharmaceutical procurement or regulatory affairs, and strong documentation skills. The officer will coordinate with international manufacturers, handle tender submissions through EPSS, and maintain regulatory records while ensuring adherence to Good Distribution Practice and other quality standards.

CHEERFUL TRADING PLC

JOB DESCRIPTION

Pharmaceutical Regulatory Affairs Officer

Department: Pharmaceutical Import & Regulatory Affairs
Location: Addis Ababa, Ethiopia
Employment Type: Full-time
Reports To: General Manager / Head of Pharmaceutical Business

1. Company Background

Cheerful Trading PLC is an Ethiopian import-export company engaged in pharmaceuticals, medical supplies, medical equipment, laboratory products, general trading, and agricultural exports.The company works with international pharmaceutical manufacturers,

As part of the continued development of its pharmaceutical import business, Cheerful Trading PLC seeks a qualified and experienced Pharmaceutical Regulatory Affairs Officer to coordinate regulatory activities, facilitate pharmaceutical product registrations, support import approvals, and ensure compliance with applicable Ethiopian regulatory requirements.

1. Position Summary

The Pharmaceutical Regulatory Affairs Officer will be responsible for coordinating all regulatory activities related to the registration, importation, and continued regulatory compliance of pharmaceutical products.

The officer will serve as the company's primary regulatory contact with the Ethiopian Food and Drug Authority (EFDA) and collaborate with international pharmaceutical manufacturers to prepare, submit, monitor, and maintain regulatory applications.

The successful candidate must have strong technical knowledge, excellent documentation skills, and practical experience with pharmaceutical product registration and importation in Ethiopia.

1. Key Duties and Responsibilities

A. Pharmaceutical Product Registration

1. Prepare, compile, review, and submit pharmaceutical product registration dossiers to EFDA.

2. Coordinate the collection of required registration documents from overseas manufacturers.

3. Review Common Technical Document (CTD) dossiers and relevant administrative and technical requirements.

4. Submit new product applications through the applicable EFDA electronic registration systems.

5. Follow up registration applications and respond to EFDA deficiency letters and technical queries in consultation with manufacturers.

6. Coordinate product registration renewals, variations, and amendments.

7. Maintain an updated database of registered products, pending applications, registration numbers, and renewal deadlines.

8. Ensure submitted product information, specifications, labelling, and packaging documents meet applicable regulatory requirements.

B. Import Permits and Regulatory Clearance

1. Prepare and coordinate pharmaceutical import permit applications through EFDA.

2. Verify the regulatory approval status of products before shipment.

3. Review proforma invoices and relevant shipment documentation for regulatory consistency.

4. Coordinate with the procurement and logistics departments to facilitate import approval and regulatory port clearance.

5. Monitor expiry dates of permits, registrations, and related regulatory documents.

6. Support resolution of regulatory issues that could delay product importation.

C. International Manufacturer Coordination

1. Establish effective regulatory communication with international manufacturers ,  and other approved manufacturers.

2. Request and review regulatory documentation from manufacturers, as applicable, including:

• Certificate of Pharmaceutical Product (CPP)

• Good Manufacturing Practice (GMP) certificates

• Manufacturing licenses

• CTD dossiers

• Certificates of Analysis (CoA)

• Product specifications and stability documentation

• Product labeling and packaging information

• Authorization letters and other required documents

• Follow up with manufacturers to resolve dossier deficiencies.

• Coordinate timely submission of revised documents, variations, and updated certificates.

• Maintain professional communication with manufacturers regarding EFDA requirements and regulatory timelines.

D. Regulatory Compliance and Quality Coordination

1. Monitor applicable EFDA regulations, directives, guidelines, and procedural updates.

2. Support compliance with Good Distribution Practice (GDP) and Good Storage Practice (GSP) requirements.

3. Coordinate regulatory responses related to product quality complaints, recalls, and safety issues.

4. Support pharmacovigilance reporting and post-marketing regulatory obligations in coordination with designated responsible personnel and manufacturers.

5. Assist management in preparing for regulatory inspections.

6. Maintain organized, accurate, confidential, and accessible regulatory records.

7. Identify regulatory risks and promptly report potential compliance issues to management.

E. Regulatory Planning and Business Support

1. Provide regulatory feasibility assessments for pharmaceutical products under consideration for importation.

2. Advise management regarding documentation requirements, registration pathways, estimated timelines, and regulatory risks.

3. Work with procurement and commercial teams to prioritize product registration activities.

4. Prepare monthly regulatory progress reports.

5. Recommend improvements to regulatory documentation and internal workflows.

F. Government Procurement, EPSS & Tender Management

1. Government and EPSS Tender Monitoring

• Regularly monitor pharmaceutical tenders issued by EPSS, government agencies, public hospitals, and other public healthcare institutions.

• Identify relevant tender opportunities based on the company's pharmaceutical product portfolio and manufacturing partnerships.

• Review tender announcements, eligibility criteria, technical specifications, submission deadlines, and regulatory requirements.

• Tender Preparation and Submission

• Prepare and coordinate technical and regulatory documentation required for pharmaceutical tender participation.

• Review bidding documents and ensure compliance with technical specifications and tender requirements.

• Coordinate the preparation of technical bids with manufacturers, procurement personnel, and management.

• Facilitate timely submission of complete tender documentation.

• Support preparation of clarification responses and tender-related correspondence.

• EPSS Regulatory and Technical Compliance

• Ensure that pharmaceutical products offered in government tenders meet applicable EFDA registration and regulatory requirements.

• Verify the availability and validity of product registration certificates, GMP certificates, manufacturing licenses, and other required documentation.

• Coordinate with international pharmaceutical manufacturers to obtain required technical documentation.

• Identify and address regulatory gaps that could affect tender eligibility.

• International Manufacturer Tender Coordination

• Communicate with Scott-Edil Pharmacia Ltd., NCPC, Theon Pharmaceuticals Ltd., and other manufacturing partners regarding tender opportunities.

• Request product specifications, regulatory documentation, manufacturer authorizations, and technical information required for bids.

• Coordinate manufacturer responses to technical clarifications and documentation requests.

• Support the commercial team in obtaining manufacturer quotations and supply commitments.

• Government Contract and Award Follow-Up

• Monitor tender evaluation results and contract award notifications.

• Coordinate with procurement, logistics, finance, and management following successful tender awards.

• Support compliance with contractual regulatory and technical requirements.

• Assist with required documentation for delivery, inspection, and acceptance of pharmaceutical products.

• Institutional Relationships and Reporting

• Maintain professional working relationships with EPSS, government healthcare institutions, and relevant procurement stakeholders.

• Ensure that all tender interactions comply with applicable procurement rules and ethical business practices.

• Maintain a tender participation database showing submitted bids, results, award status, outstanding requirements, and deadlines.

• Prepare monthly government tender participation and regulatory progress reports.

• At least 2 years of direct experience in Ethiopian government pharmaceutical procurement, EPSS tender participation, or equivalent institutional pharmaceutical tender activities.

• Practical experience preparing pharmaceutical technical tender documents.

• Knowledge of EPSS procurement processes and public pharmaceutical tender requirements.

• Experience coordinating pharmaceutical product documentation with international manufacturers.

• Familiarity with EFDA pharmaceutical product registration and import-permit procedures.

• Experience reviewing pharmaceutical tender specifications and responding to technical clarifications.

• Strong understanding of tender documentation, compliance requirements, and submission deadlines.

Highly Desirable Experience

• Previous employment with a pharmaceutical importing company that has participated in EPSS tenders.

• Hands-on participation in successful pharmaceutical tender submissions or contract awards.

• Experience with public hospital and government institutional pharmaceutical procurement.

• Familiarity with applicable Ethiopian electronic procurement and tender submission platforms.

• Experience coordinating overseas pharmaceutical manufacturers for government supply contracts.

Job Requirements

1. Educational Qualifications

Minimum requirements:

• Bachelor of Pharmacy (BPharm) or equivalent recognized pharmacy qualification.

• Preferably 3–5 years of relevant professional experience in pharmaceutical regulatory affairs, pharmaceutical importing, or product registration.

• Practical knowledge of EFDA requirements and pharmaceutical registration procedures.

• Demonstrated experience handling pharmaceutical regulatory documents.

Preferred qualifications:

• Previous experience in a licensed Ethiopian pharmaceutical importing or distribution company.

• Practical experience using EFDA electronic regulatory systems.

• Familiarity with CTD dossier evaluation and GMP documentation.

• Experience communicating with foreign pharmaceutical manufacturers.

1. Essential Skills and Competencies

• Strong understanding of Ethiopian pharmaceutical regulatory requirements.

• Good knowledge of pharmaceutical product registration and import procedures.

• Ability to review technical and administrative registration documents.

• Excellent English communication and professional writing skills.

• Strong organization, attention to detail, and document management.

• Proficiency in Microsoft Office, especially Excel, Word, and Outlook.

• Strong follow-up, problem-solving, and time-management skills.

• Professional integrity, accountability, and confidentiality.

• Ability to work independently and coordinate with multiple departments.

1. Reporting Requirements

The Pharmaceutical Regulatory Affairs Officer shall submit a monthly report covering:

• New registration applications submitted.

• Products approved and pending registration.

• Outstanding EFDA queries and deficiencies.

• Manufacturer documents awaiting submission.

• Product registration renewal schedules.

• Import permits submitted and approved.

• Regulatory challenges, risks, and corrective action plans.

• Planned regulatory activities for the following month.

1. Authority and Accountability

The officer is authorized to coordinate regulatory applications and communicate with relevant authorities and manufacturers within the scope delegated by company management.

The officer must not independently commit the company to commercial agreements, issue unauthorized regulatory declarations, or approve the release of pharmaceutical products without the required internal and regulatory authorization.

Where Ethiopian law requires a designated licensed pharmacist, technical manager, pharmacovigilance responsible person, or another formally approved professional, the officer shall perform those functions only if appropriately qualified and designated.

1. Expected Outcomes

The successful candidate is expected to establish an efficient regulatory affairs function that supports Cheerful Trading PLC in achieving:

• A well-organized pharmaceutical registration portfolio.

• Improved regulatory coordination with foreign pharmaceutical manufacturers.

• Reduced avoidable documentation deficiencies and regulatory delays.

• Timely management of regulatory submissions and renewals.

• Reliable support for compliant pharmaceutical importation.

• Sustainable growth of the company's pharmaceutical business.

How To Apply

Interested and qualified applicants can apply through the following email address munajaabdela18@gmail.com

.

• Position Summary The Pharmaceutical Regulatory Affairs Officer will be responsible for coordinating all regulatory activities related to the registration, importation, and continued regulatory compliance of pharmaceutical products.

The officer will serve as the company's primary regulatory contact with the Ethiopian Food and Drug Authority (EFDA) and collaborate with international pharmaceutical manufacturers to prepare, submit, monitor, and maintain regulatory applications.

The successful candidate must have strong technical knowledge, excellent documentation skills, and practical experience with pharmaceutical product registration and importation in Ethiopia.

• Key Duties and Responsibilities A. Pharmaceutical Product Registration
• Prepare, compile, review, and submit pharmaceutical product registration dossiers to EFDA.
• Coordinate the collection of required registration documents from overseas manufacturers.
• Review Common Technical Document (CTD) dossiers and relevant administrative and technical requirements.
• Submit new product applications through the applicable EFDA electronic registration systems.
• Follow up registration applications and respond to EFDA deficiency letters and technical queries in consultation with manufacturers.
• Coordinate product registration renewals, variations, and amendments.
• Maintain an updated database of registered products, pending applications, registration numbers, and renewal deadlines.
• Ensure submitted product information, specifications, labelling, and packaging documents meet applicable regulatory requirements.

B. Import Permits and Regulatory Clearance

• Prepare and coordinate pharmaceutical import permit applications through EFDA.
• Verify the regulatory approval status of products before shipment.
• Review proforma invoices and relevant shipment documentation for regulatory consistency.
• Coordinate with the procurement and logistics departments to facilitate import approval and regulatory port clearance.
• Monitor expiry dates of permits, registrations, and related regulatory documents.
• Support resolution of regulatory issues that could delay product importation.

C. International Manufacturer Coordination

• Establish effective regulatory communication with international manufacturers , and other approved manufacturers.
• Request and review regulatory documentation from manufacturers, as applicable, including:
• Certificate of Pharmaceutical Product (CPP)
• Good Manufacturing Practice (GMP) certificates
• Manufacturing licenses
• CTD dossiers
• Certificates of Analysis (CoA)
• Product specifications and stability documentation
• Product labeling and packaging information
• Authorization letters and other required documents
• Follow up with manufacturers to resolve dossier deficiencies.
• Coordinate timely submission of revised documents, variations, and updated certificates.
• Maintain professional communication with manufacturers regarding EFDA requirements and regulatory timelines.

D. Regulatory Compliance and Quality Coordination

• Monitor applicable EFDA regulations, directives, guidelines, and procedural updates.
• Support compliance with Good Distribution Practice (GDP) and Good Storage Practice (GSP) requirements.
• Coordinate regulatory responses related to product quality complaints, recalls, and safety issues.
• Support pharmacovigilance reporting and post-marketing regulatory obligations in coordination with designated responsible personnel and manufacturers.
• Assist management in preparing for regulatory inspections.
• Maintain organized, accurate, confidential, and accessible regulatory records.
• Identify regulatory risks and promptly report potential compliance issues to management.

E. Regulatory Planning and Business Support

• Provide regulatory feasibility assessments for pharmaceutical products under consideration for importation.
• Advise management regarding documentation requirements, registration pathways, estimated timelines, and regulatory risks.
• Work with procurement and commercial teams to prioritize product registration activities.
• Prepare monthly regulatory progress reports.
• Recommend improvements to regulatory documentation and internal workflows.

F. Government Procurement, EPSS & Tender Management

• Government and EPSS Tender Monitoring
• Regularly monitor pharmaceutical tenders issued by EPSS, government agencies, public hospitals, and other public healthcare institutions.
• Identify relevant tender opportunities based on the company's pharmaceutical product portfolio and manufacturing partnerships.
• Review tender announcements, eligibility criteria, technical specifications, submission deadlines, and regulatory requirements.
• Tender Preparation and Submission
• Prepare and coordinate technical and regulatory documentation required for pharmaceutical tender participation.
• Review bidding documents and ensure compliance with technical specifications and tender requirements.
• Coordinate the preparation of technical bids with manufacturers, procurement personnel, and management.
• Facilitate timely submission of complete tender documentation.
• Support preparation of clarification responses and tender-related correspondence.
• EPSS Regulatory and Technical Compliance
• Ensure that pharmaceutical products offered in government tenders meet applicable EFDA registration and regulatory requirements.
• Verify the availability and validity of product registration certificates, GMP certificates, manufacturing licenses, and other required documentation.
• Coordinate with international pharmaceutical manufacturers to obtain required technical documentation.
• Identify and address regulatory gaps that could affect tender eligibility.
• International Manufacturer Tender Coordination
• Communicate with Scott-Edil Pharmacia Ltd., NCPC, Theon Pharmaceuticals Ltd., and other manufacturing partners regarding tender opportunities.
• Request product specifications, regulatory documentation, manufacturer authorizations, and technical information required for bids.
• Coordinate manufacturer responses to technical clarifications and documentation requests.
• Support the commercial team in obtaining manufacturer quotations and supply commitments.
• Government Contract and Award Follow-Up
• Monitor tender evaluation results and contract award notifications.
• Coordinate with procurement, logistics, finance, and management following successful tender awards.
• Support compliance with contractual regulatory and technical requirements.
• Assist with required documentation for delivery, inspection, and acceptance of pharmaceutical products.
• Institutional Relationships and Reporting
• Maintain professional working relationships with EPSS, government healthcare institutions, and relevant procurement stakeholders.
• Ensure that all tender interactions comply with applicable procurement rules and ethical business practices.
• Maintain a tender participation database showing submitted bids, results, award status, outstanding requirements, and deadlines.
• Prepare monthly government tender participation and regulatory progress reports.
• At least 2 years of direct experience in Ethiopian government pharmaceutical procurement, EPSS tender participation, or equivalent institutional pharmaceutical tender activities.
• Practical experience preparing pharmaceutical technical tender documents.
• Knowledge of EPSS procurement processes and public pharmaceutical tender requirements.
• Experience coordinating pharmaceutical product documentation with international manufacturers.
• Familiarity with EFDA pharmaceutical product registration and import-permit procedures.
• Experience reviewing pharmaceutical tender specifications and responding to technical clarifications.
• Strong understanding of tender documentation, compliance requirements, and submission deadlines.

Highly Desirable Experience

• Previous employment with a pharmaceutical importing company that has participated in EPSS tenders.
• Hands-on participation in successful pharmaceutical tender submissions or contract awards.
• Experience with public hospital and government institutional pharmaceutical procurement.
• Familiarity with applicable Ethiopian electronic procurement and tender submission platforms.
• Experience coordinating overseas pharmaceutical manufacturers for government supply contracts.

Job Requirements

• Educational Qualifications Minimum requirements:
• Bachelor of Pharmacy (BPharm) or equivalent recognized pharmacy qualification.
• Preferably 3–5 years of relevant professional experience in pharmaceutical regulatory affairs, pharmaceutical importing, or product registration.
• Practical knowledge of EFDA requirements and pharmaceutical registration procedures.
• Demonstrated experience handling pharmaceutical regulatory documents.

Preferred qualifications:

• Previous experience in a licensed Ethiopian pharmaceutical importing or distribution company.
• Practical experience using EFDA electronic regulatory systems.
• Familiarity with CTD dossier evaluation and GMP documentation.
• Experience communicating with foreign pharmaceutical manufacturers.
• Essential Skills and Competencies
• Strong understanding of Ethiopian pharmaceutical regulatory requirements.
• Good knowledge of pharmaceutical product registration and import procedures.
• Ability to review technical and administrative registration documents.
• Excellent English communication and professional writing skills.
• Strong organization, attention to detail, and document management.
• Proficiency in Microsoft Office, especially Excel, Word, and Outlook.
• Strong follow-up, problem-solving, and time-management skills.
• Professional integrity, accountability, and confidentiality.
• Ability to work independently and coordinate with multiple departments.
• Reporting Requirements The Pharmaceutical Regulatory Affairs Officer shall submit a monthly report covering:
• New registration applications submitted.
• Products approved and pending registration.
• Outstanding EFDA queries and deficiencies.
• Manufacturer documents awaiting submission.
• Product registration renewal schedules.
• Import permits submitted and approved.
• Regulatory challenges, risks, and corrective action plans.
• Planned regulatory activities for the following month.
• Authority and Accountability The officer is authorized to coordinate regulatory applications and communicate with relevant authorities and manufacturers within the scope delegated by company management.

The officer must not independently commit the company to commercial agreements, issue unauthorized regulatory declarations, or approve the release of pharmaceutical products without the required internal and regulatory authorization.

Where Ethiopian law requires a designated licensed pharmacist, technical manager, pharmacovigilance responsible person, or another formally approved professional, the officer shall perform those functions only if appropriately qualified and designated.

• Expected Outcomes The successful candidate is expected to establish an efficient regulatory affairs function that supports Cheerful Trading PLC in achieving:
• A well-organized pharmaceutical registration portfolio.
• Improved regulatory coordination with foreign pharmaceutical manufacturers.
• Reduced avoidable documentation deficiencies and regulatory delays.
• Timely management of regulatory submissions and renewals.
• Reliable support for compliant pharmaceutical importation.
• Sustainable growth of the company's pharmaceutical business.