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Summary of the Position
The Senior Technical Advisor, Chemistry, Manufacturing and Controls (CMC) and Regulatory Systems Strengthening will have expert skills in pharmaceutical manufacturing, dossier evaluations/submission and inspection. He/she must understand the pharmaceutical development process from pre-clinical development through life cycle management. The selected candidate will be responsible for providing specialized technical assistance in the areas of regulatory systems strengthening with emphasis on dossier assessment/evaluation and conducting manufacturing facility audits for compliance to current Good Manufacturing Practice (GMP). He/she will initiate the development of regulations, directives, manuals, guidelines, procedures, and other relevant tools and promotes their proper implementation. The incumbent will serve as a focal point for initiatives to build capacity of manufacturers in order to institute good practices for ensuring medicines quality at various stages including medicine production, registration, market authorization/ licensing and inspection. As the lead for PQM+ pharmaceutical manufacturing and regulatory activities in Kenya, Ethiopia and other countries, the Senior Technical Advisor provides technical oversight related to the program’s objective of increasing the supply of quality-assured, essential medical products, including provision of technical assistance to manufacturers (including, product development, good manufacturing practices, dossier development and submission). Additionally, he/ she acts is a recognized leader, interfacing with the regional regulatory bodies and stakeholders involved in supplying and manufacturing essential medicines.
Roles and Responsibilities
· Provides technical oversight of activities to support local manufacturers in the region to implement and comply with GMPs and in the development of dossiers to submit for WHO prequalification.
· Leads in the provision of technical assistance to regional regulatory bodies particularly in the areas of good manufacturing practice (GMP) compliance audit and pharmaceutical product dossier evaluation.
· Designs and implement interventions aimed at strengthening overall regulatory systems and improving medicine quality assurance systems in multiple countries including the development and implementation of regulations, directives, manuals, guidelines, procedures and other relevant tools.
· Provides technical leadership and ongoing support to regulatory bodies to improve efficiency and effectiveness of the medicine marketing authorization process.
· Manages technical assistance and advises in the development of tools for marketing authorization, clinical trial approval and compliance to good clinical practice (GCP).
· Provide training in dossier assessment, GMP compliance, good distribution practice (GDP), good storage practice (GSP) and good inspection techniques for staff at national regulatory bodies.
· Support building capacity of regional medicine regulatory bodies in the development of regulatory tools and inspection of the distribution channel and retail outlets of pharmaceutical products.
· Work closely with country team to support development and deployment of strategies in pharmaceutical sector development
· Actively contribute to annual programmatic and resource planning process and to the development of quarterly and annual reports
• Minimum of 8 + years of experience leading and implementing technical assistance programs in expanding access to global health products and pharmaceuticals
• Bachelor’s degree in pharmacy, pharmaceutical science, chemistry, engineering or science related field of study required
• Working understanding of Chemistry, Manufacturing and Controls, good manufacturing practices, dossier evaluation and inspection**
• Direct experience implementing USAID-funded programs
• Direct experience with and understanding of WHO pre-qualification process
• Strong written (especially technical writing) and oral communication skills
• Experience of working with regional regulatory bodies and/or local manufacturers
• Willingness to travel at least 25% of the time.**
· Minimum 3+ years of people management experience and skills
· Experience in at least one of the following health areas: HIV/ AIDS, malaria, TB, NTDs, AMR, MNCH
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