Technical Implementation:

• Provide technical leadership to develop and implement interventions necessary to strengthen the regulatory system of Kenya to attain a higher WHO GBT maturity level including but not limited to the areas of marketing authorization, regulatory inspections, licensing of establishments, vigilance, market surveillance and control including risk-based post marketing surveillance, and Antimicrobial stewardship (AMS), etc.
• Work with the Pharmaceutical Management Director and other project staff to optimize processes and resources to improve efficiency in implementing identified RSS interventions.
• Maintain high-quality standards in the implementation of RSS interventions in collaboration with government, private sector counterparts and other project staff.
• Identify and mitigate risks that may affect KIPS’ ability to deliver high quality and timely RSS interventions, and escalate to the Pharmaceutical Management Director.
• Drive the integration of novel thinking in the delivery of RSS interventions, aligning interventions with new thinking and best practices in the sector, making sure to link regulatory system interventions with improving the pharmaceutical supply chain.
• Provide specific technical assistance to the regional offices of PPB and relevant county entities in monitoring the quality of HPTs through post-marketing surveillance, reporting of adverse drug events, and other medicine related issues to ensure patient safety.
• Collaborate with the AMR and Rational Use Manager on designing and implementing interventions aimed at strengthening AMS and appropriate use of medicines and enhancing patient safety. 
• Support efforts to enhance regional reliance, work sharing, and other regional collaborative efforts related to RSS.
• Ensure collection of good quality data to support progress monitoring towards achieving relevant RSS and AMS indicators.
• Develop and deliver training programs to enhance RSS and build government counterparts capacity to sustainably move toward technical independence.
• Build and maintain strong relationships with stakeholders involved in RSS and represent the KIPS project at RSS engagements with relevant stakeholders
• Perform any additional regulatory system strengthening activities as may be required by the donor, USP or DAI to support successful project implementation.

Who is USP Looking For?

• The successful candidate will have a demonstrated understanding of our mission, commitment to excellence through inclusive and equitable behaviors and practices, ability to quickly build credibility with stakeholders, along with the following competencies and experience:
• Master’s degree or equivalent in Regulatory Science, Pharmacy, Pharmaceutical Science, Public/Global Health, Medicine, Chemistry, Biology, Pharmacovigilance, or related fields
• Minimum of five years of relevant experience in medicine regulation with at least four years of experience working with or supporting a national or regional medicines regulatory authority on one or more of the key regulatory functions including pharmacovigilance and patient safety
• Demonstrated experience with the WHO global benchmarking tool is required.
• Excellent understanding of supply chain and the pharmaceutical development process from pre-clinical development through life cycle management Experience working and currently residing in Kenya is required
• Experience in training, and mentoring government and private sector stakeholders
• Ability to work in a fast-paced environment and quickly adapt to changes and respond to donor demands
• Ability to travel locally
• Excellent written and oral communication skills with ability to produce quality, coherent and informative reports
• Fluency in English is required