Senior Advisor – Pharmaceutical Regulatory System Strengthening

MAIN PURPOSE OF JOB:   

The Senior Advisor will provide high-level strategic and technical support to the Ethiopian Food and Drug Authority (EFDA) to strengthen pharmaceutical regulatory systems, improve regulatory service efficiency, including import and customs clearance processes for priority health commodities and institutionalize traceability and digital systems, including supporting the smooth, GS1 standards compliant national rollout of the pharmaceutical track-and-trace system in coordination with the EFDA-MVC Traceability Hub (EFDA’s partnership with Medical Value Chain (MVC)), and sustaining the continued functioning of e-RIS. The advisor will also advance EFDA’s readiness for International Organization for Standardization (ISO) 9001:2015 Quality Management System certification. The Advisor will support regulatory measures that ensure the safe, effective, quality-assured, and rational use of medicines in Ethiopia; strengthen EFDA’s capacity for evidence-based, performance-driven regulatory decision-making; and build sustainable institutional capacity through mentoring, coaching, and knowledge transfer to assigned EFDA staff. The Advisor will support EFDA in improving regulatory performance across both product regulation and post-market authorization oversight, with special focus on USG-funded public health commodities.                                                    

RESPONSIBILITIES:

Under supervision of the Deputy Chief of Party of the USG SCS Project and working under EFDA’s Director General’s Office, the Senior Advisor will carry out the following responsibilities:

• Provide strategic advisory support to EFDA leadership on pharmaceutical regulatory system strengthening.
• Provide technical assistance on the review, drafting, revision, and operationalization of Proclamations, Regulations, Directives, Guidelines, and Standard Operating Procedures (SOPs) related to pharmaceutical regulation with focus on product registration, customs clearance, product traceability, and eRIS implementation.
• Support harmonization of national regulatory frameworks with international standards including World Health Organization (WHO), ISO 9001 and GS1   standards, and Good Regulatory Practices Support on establishment and/or strengthening of governance structures such as technical working groups, steering committees, and regulatory review forums.
• Provide technical input into regulatory reform initiatives and institutional strengthening plans.

• Support efficient regulatory review and approval of import permits and customs clearance for USG-supported health commodities.
• Identify regulatory bottlenecks affecting registration and customs clearance, and propose corrective measures.
• Support development of streamlined regulatory pathways for emergency health commodities and health program health commodities.

• Provide technical support on operationalization of the national pharmaceutical traceability roadmap
• Support on strengthening EFDA’s Traceability Office and coordination of traceability steering committees and TWGs

• Support on enforcement of GS1-compliant product identification requirements.
• Support rollout of GTIN, barcode systems, serialization and data exchange

• Facilitate interoperability between traceability platforms and national systems.

• Support capacity assessment of manufacturers, importers, wholesalers, and health facilities.
• Support piloting and phased implementation of the Traceability System.

• Support overall digitization initiative of EFDA with due attention to the optimization and scale-up of eRIS.
• Assess business processes and identify opportunities for digital transformation.
• Promote interoperability between eRIS, EPSS ERP, customs systems, pharmacovigilance systems, traceability systems, and laboratory systems
• Support dashboard development, and data analytics and use for regulatory decision-making.

• Strengthen systems for monitoring safety, quality, and efficacy of regulated products.
• Support risk-based post-market surveillance for priority commodities.
• Support investigation of substandard, falsified, and smuggled products
• Support recall and corrective action mechanisms using traceability data.

• Support EFDA in conducting a gap assessment of core regulatory and administrative processes against ISO 9001:2015 Quality Management System requirements.
• Coordinate closely with EFDA's QMS Lead Executive Officer and existing quality management structures to align certification-readiness activities with ongoing institutional QMS initiatives and avoid duplication of effort.
• Support development and revision of quality manuals, process maps, document control procedures, internal audit protocols, and corrective and preventive action (CAPA) systems required for ISO 9001:2015 certification.
• Facilitate internal quality audit training and coordinate mock/pre-assessment audits ahead of engagement with an accredited external certification body.
• Advise EFDA leadership on the selection and engagement of an accredited ISO certification body and support preparation of the certification application and audit logistics.
• Align ISO 9001:2015 QMS documentation and process improvements with the WHO Global Benchmarking Tool (GBT) framework to help sustain and advance EFDA's WHO Maturity Level 3 status, noting that ISO certification and WHO GBT maturity assessment are complementary but distinct processes with different scopes and assessment bodies.
• Undertake other related activities as assigned by the supervisors from SCS and EFDA side

QUALIFICATIONS

REQUIRED MINIMUM EDUCATION

Advanced degree (Master’s or higher) in pharmaceutical sciences or regulatory sciences.

REQUIRED MINIMUM EXPERIENCE:         

• A minimum of 8 years of related experience is required in pharmaceutical regulation or pharmaceutical supply chain systems
• 10 years of progressively responsible experience is preferred. 
• Experience in international public health highly preferred.     
• Demonstrated experience in pharmaceutical policy, import regulation, quality assurance, digital health systems, and regulatory information systems
• Experience working with donor-funded programs preferred
• Fluency in English required; working knowledge of Amharic preferred.
• Experience in supporting ISO 9001:2015 QMS gap assessment, documentation, or certification processes – ideally within a regulatory authority or public health institution – strongly preferred.

KNOWLEDGE AND SKILLS:             

• Knowledge on the health products regulatory and supply chain systems of Ethiopia.
• Knowledge and experience on track-and-trace system as per GS1 standards is strongly preferred
• Strong understanding of end-to-end pharmaceutical supply chain and pharmacy service systems and recent initiatives being implemented in the country
• Excellent leadership and strategic thinking skills
• Strong facilitation, coordination, and stakeholder engagement capacity
• High-level communication and report writing skills in English Language
• Ability to work effectively in complex, multi-partner environments
• Strong organizational and problem-solving skills
• Skill on monitoring, evaluation, data analytics and use of data for decision-making

COMPETENCIES:      

• Results seeker – Proactive, meets deadlines, identifies actions, and achieves goals.
• Innovator – thinks creatively, anticipates changes, and produces solutions.
• Adaptor – stays calm under pressure and handles constructive criticism well.
• Complier – follows procedures and encourages others to do as well.

MSH is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or any other protected category under applicable federal, state, and local laws. MSH complies with Section 503 of the Rehabilitation Act, Section 4212 of the Vietnam Era Readjustment Assistance Act, as amended, and all related applicable regulations.

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