John Tafao
Nairobi
Summary
Demonstrable experience working, collaborating, partnering and engaging with Global Health Partners. Experience with biotech/pharmaceutical industries in product development, regulatory in medicines, vaccines and diagnostics. Abilities to engage, presenting to leadership teams, national, world listed authorities and abilities to influence without direct authority. Experience in supporting, working with cross-functional teams market shaping, resource mobilization, country programs, allocation supply chain and legal. Proven track record to adapt quickly in a fast paced environment pandemic, epidemic, accelerated product authorizations and emergency use listing at WHO, capacity building, regulatory system strengthening and advocacy for global health security.
Overview
24
24
years of professional experience
Work History
Director Regulatory Affairs Africa
International AIDS Vaccine Initiative
04.2024 - 09.2024
- Developed partnerships with National Regulatory Authorities, Research Institutions, Ethics Committees, Industry, AVAREF and Gates Foundation on pathways to accelerate clinical trial reviews and future product introduction.
- Provided strategic regulatory, project lead support in clinical trials for vaccine development, documentation check-list for submission and approval.
- Contributor, collaborator with scientists in writing briefs; Investigator Brochure, Study Protocol, literature reviews and progress report presentation to donor.
- Regulatory focal point, representative in internal cross-functional, external/partner project initiatives.
- Support in Regulatory Intelligence monitoring, gathering, guideline interpretation and collaborating with internal and external teams in development, shaping and sustaining of best practices.
- Advocate in external working groups on public-private-partnerships, Africa harmonized approach to accelerated product development for Africa.
- Convening, delivering regulatory presentations to internal and external partners, seeking alignment, coalition and capacity building.
- Market shaping through engagements in strengthening regulatory systems.
Senior Manager Manufacturer Engagement, Regulatory
Global Alliance of Vaccines for Immunization
07.2021 - 12.2023
- Engaged manufacturers (including scale ups, tech-transfer in India, China). Coordinated R&D aligned rolling submission strategy for emergency use authorization, emergency use listing to Covid-19 Vaccines for COVAX global supply.
- Contributor in drafting, resource mobilization, design of market shaping strategies, identification of program opportunities, risks, building relationships with alliance partners strengthening pandemic prevention, preparedness.
- Engagements with WHO PQ Head and UNICEF Supply Division, product pipeline reviews, investment analysis, assessment of market barriers in LMICs (Africa), preparation presentations and media briefs for GAVI Leadership.
- Thought partner in the Deal Team strategy development, decision making processes that secured and implemented agreements with manufacturers.
- GAVI focal with national, world listed regulatory authorities, Industry and support to market shaping teams in product development engagements. Investment portfolio gap analysis, communication of opportunities, risks on new manufacturing initiatives that optimize impact access equity from grant execution.
- In-depth knowledge of Global Health R&D innovation systems, Programs for LMICs, multi-lateral stakeholder engagement and policy communication.
- GAVI representative in WHO-CEPI led Global Regulatory Advisory Group meetings updating internal stakeholders-highlights and decisions.
- Led cross-functional teams in assessments for demand certainty, supply, contract manufacturing, technology transfers, intellectual-property advisory and compliance.
- Built, strengthened global health partnerships for successful vaccine delivery of donations, follow-ups with WHO on Emergency Use Listing for country supply and handling complex deliveries for multiple regions.
- Demonstrated experience in working with multiple programs, adaptive in fast pandemic environment, networking, coalition-building in Global Health.
- Advocated for Africa Medicines Agency, National Regulatory Systems through WHO Global Benchmarking Tools (GBT) and Maturity levels that will incentivize innovation, scale ups, technology transfer, for diagnostics, medicines and vaccines for Africa.
Senior Regulatory Expert Global Public Health
Janssen Pharmaceuticals, Johnson & Johnson
08.2019 - 06.2021
- Industry advocacy in innovative research and development of vaccines, medicines and diagnostics that address health priorities in Africa
- Timely communication of insights from National Regulatory Authorities in Africa, AVAREF for accelerated reviews for priority vaccines.
- Engagements with Regulatory Authorities on technical support, capacity building gaps, safety, regulations on vaccine product development and authorizations.
- Advocate in the development, implementation of harmonized regulatory pathways, strategy, and guidance for emergency responses in epidemics and pandemic preparedness.
- Project lead in formulating, executing collaborative registration procedure strategy with WHO-AFRO and Africa national regulators for Ebola Vaccine.
Government and External Affairs Manager
British America Tobacco
01.2019 - 07.2019
- Stakeholder mapping and implementing a stakeholder management system.
- Developed policies, regulations intelligence monitor for awareness, advisory and risk mitigation.
- Engagement with regulatory authority on a process to introduce new potentially reduced risk nicotine product.
- Excise Plans/Engagement, legislations and security support in managing Illicit Tobacco Trade in East Africa and succeeded in phased implementation of electronic tax stamps with no impact to business
- Regulatory interventions in Tobacco Bill 2018 with national government.
Regulatory Affairs Manager
Merck Healthcare
09.2017 - 12.2018
- Managed Regulatory Operations transition from Distributors to Merck Healthcare.
- Pharmaceutical distributor relationship management.
- Strengthened relationships with Health Authorities in East Africa, Southern Africa regions, Quality Control Laboratories advocating procurement of USP reference standards for quality medicines.
- Negotiated, Influenced adoption of GMP desktop reviews for manufacturing sites in world listed authority jurisdictions reducing product registration timelines.
- Regional Qualified Person for Pharmacovigilance.
Head of Regulatory
Serenus Biotherapeutics
01.2016 - 07.2017
- Coordinated and managed all regulatory activities in strategic Africa markets.
- Built and strengthened relationships with regulatory authorities, negotiating and influencing regulatory environment with support of industry associations.
- Representing Company in Regulatory Audits/Good Manufacturing Practice Assessments/Visits.
- Author Regulatory Standard Operating Procedures- New Product Introduction, Life-Cycle and Change Control Management.
- Managing consultants and Regulatory Department Budget for Africa.
Shared Pack Coordinator, Africa Regulatory Hub
GlaxoSmithKline
08.2015 - 01.2016
- Optimal label implementation, maintenance through shared packs for ease of supply.
- Supporting artwork coordination and global alignment to new Core Safety Data Sheets/Prescribing Information.
- Planning meetings, leading development, coordination of adequacy assessment of dossiers, and variation packages.
- Alignment of trade-names/marks across in Africa liaising with Corporate Legal and Therapeutic Leads.
- Regulatory compliance through use of Regulatory Information Systems.
- Collaboration with Global Regulatory, support in authoring all response to regulatory queries, intelligence and implementation of strategy.
- Training artwork proof reading techniques and annual certification for Africa for optimal compliance.
- Africa artwork lead in identifying risks, assessed and escalated for mitigation.
- Ensured synergy, best practices on pack and artwork management in end-end liaising with supply chain.
- Led Sub-Sahara Africa Regulatory Hub Team Meetings on all submission planning, escalation of bottle-necks for priority resolution.
Senior Regulatory and Quality Executive
GlaxoSmithKline
03.2005 - 07.2015
- Compiled submissions for marketing authorizations-vaccines, innovator, ARVs private/access markets, devices
- Extensive experience in vaccines development, Marketing Authorizations of Rotarix, Synflorix and Cervarix Vaccines first in Africa through formulated regional strategy for accelerated approval, using article 58 procedure/pathway
- Submission and Marketing Authorization of GlaxoSmithKline`s main vaccines Engerix, Havrix, Priorix, Priorix Tetra, Mencevax ACWY, Twinrix, Hiberix, Infanrix, Infanrix-Hexa, Polio and Varilrix Vaccine
- In-depth experience and support on GMP audits from Regulatory Agencies, Global Internal Audits, Quality Support in Supply Chain, Risk assessment and management, CAPA Management, Medical Governance-Non-compliance case awareness, corrective action, escalation, training business units, QMS Champion, Level 1, 2 Internal Auditor for Continuous Improvement initiatives
- Presentations, Engagements with MOH, Public Health Stakeholders and HCP Key Opinion Leaders for accelerated approvals and acceptance of Rotarix Vaccine, Synflorix Vaccine in Expanded Programme for Immunization-availability in all public hospitals in East Africa through GAVI/Government Public-Private Partnerships.
Global Volunteer
GlaxoSmithKline
08.2013 - 02.2014
- Corporate Social Responsibility-Skills, knowledge and competencies sharing at JHPIEGO Lusaka, Zambia.
Medical Representative
GlaxoSmithKline
07.2004 - 12.2004
- Pharmaceuticals promotion for market access, brand awareness.
Regulatory Affairs Assistant
GlaxoSmithKline
05.2000 - 07.2004
- Preparation, submission of product registrations to regulatory authorities for marketing authorization and lifecycle maintenance.
- Global Supply Network Project Lead Africa-Regulatory Subject Matter Expert on CMC and Life-Cycle Management.
- Rationalization, harmonization of supply sites improving efficiency in global manufacturing and supply.
- Gathering market regulatory intelligence, CMC and Quality Control change management, timely communication, interpretations and guideline advisory and mitigating supply risks.
- Stakeholder updates on milestones, regulatory guideline/policy intelligence, awareness of sensitivities and managing expectations
- GMP applications, Follow-Up for Inspections, CAPA closures and Africa License repository of all global sites.
Education
Bachelor of Science - Biological Sciences and Chemistry
Biological Sciences
Jomo Kenyatta University of Agriculture Technology
Nairobi, Kenya04-1999
Skills
- In-depth regulatory experience with global pharmaceutical industries
- Industry experience in medicines, vaccines and diagnostics
- Global Health Partner/s engagement and management consulting experience
- Thought partner in gathering global health ecosystem intelligence, analyzing trends for informed, impactful interventions
- Drafting, contributing, preparing presentations, briefing notes, progress reports for internal and external meetings
- Market shaping support at country, global level, contributing in developing strategies, investment portfolio analysis with suppliers to optimize impact
- Ability to timely, clearly communicate, build, develop trust relationships and influencing decisions
- Ability to develop, maintain relationships with internal teams, external partners
- Ability to develop, maintain relationships with internal teams, external partners
- Managing, avid user of information tracking systems and databases
- Business acumen and entrepreneur mind
- Abilities to apply effective leadership and interpersonal skills using strategic thinking, team and project leadership, analytical and decision making skills
- Ability to develop, maintain relationships with internal teams, external partners
Languages
English
Kiswahili
Personal Information
Nationality: Kenyan
Timeline
Director Regulatory Affairs Africa
International AIDS Vaccine Initiative
04.2024 - 09.2024
Senior Manager Manufacturer Engagement, Regulatory
Global Alliance of Vaccines for Immunization
07.2021 - 12.2023
Senior Regulatory Expert Global Public Health
Janssen Pharmaceuticals, Johnson & Johnson
08.2019 - 06.2021
Government and External Affairs Manager
British America Tobacco
01.2019 - 07.2019
Regulatory Affairs Manager
Merck Healthcare
09.2017 - 12.2018
Head of Regulatory
Serenus Biotherapeutics
01.2016 - 07.2017
Shared Pack Coordinator, Africa Regulatory Hub
GlaxoSmithKline
08.2015 - 01.2016
Global Volunteer
GlaxoSmithKline
08.2013 - 02.2014
Senior Regulatory and Quality Executive
GlaxoSmithKline
03.2005 - 07.2015
Medical Representative
GlaxoSmithKline
07.2004 - 12.2004
Regulatory Affairs Assistant
GlaxoSmithKline
05.2000 - 07.2004
Bachelor of Science - Biological Sciences and Chemistry
Biological Sciences
Jomo Kenyatta University of Agriculture Technology
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