MUGO WILSON KAMAU
Nairobi
Summary
Senior Regulatory Affairs, Quality & Compliance professional with 10+ years of experience across pharmaceutical, veterinary, and animal health product regulation within multi-country African and international markets. Proven track record in regulatory strategy, market authorization, and product lifecycle management, having successfully led multi-jurisdictional registration portfolios exceeding 50 products across East Africa, Ethiopia, and Pakistan. Highly skilled in ACTD/CTD dossier development, GMP compliance, regulatory submissions, inspections, and authority engagement, ensuring continuous product market access and regulatory compliance. Recognized for bridging regulatory, quality, supply chain, and commercial functions to support business continuity and market expansion. Strong capability in regulatory risk management, audit leadership, and cross-functional stakeholder coordination, with expertise in sustainability, environmental compliance, and ESG-aligned regulatory frameworks.
Overview
9
9
years of professional experience
Work History
Regulatory Affairs & EHS Manager
CKL Africa Ltd
07.2019 - Current
- Lead regulatory affairs, compliance, and environmental health & safety strategy across a diversified portfolio of pharmaceutical, veterinary, and animal health products operating in multiple African and international markets.
- Direct end-to-end regulatory strategy and execution across East Africa, Ethiopia, and Pakistan, ensuring continuous market authorization and compliance with evolving regulatory frameworks.
- Lead preparation, review, and submission of ACTD/CTD dossiers for 50+ regulated products, enabling successful product registrations and sustained market access.
- Manage full product lifecycle activities including registrations, renewals, variations, and regulatory updates, ensuring uninterrupted product availability in all markets.
- Serve as primary liaison with regulatory authorities, effectively managing approvals, deficiency responses, and inspection engagements.
- Provide regulatory leadership and technical guidance to QA, Supply Chain, Sales, Marketing, and Sustainability teams, embedding compliance across the business value chain.
- Lead GMP compliance programs, internal audits, and external inspection readiness, consistently achieving favorable audit outcomes.
- Review and approve product labels, packaging, and artwork, ensuring compliance with national and international regulatory requirements – WHO, GHS etc.
- Coordinate with CMOs, CROs, and external manufacturing partners to ensure regulatory compliance and timely dossier development.
- Lead regulatory risk assessments, compliance reporting, and management reviews to support strategic decision-making and business continuity.
- Oversee departmental planning, capability development, and mentoring of regulatory staff to strengthen organizational compliance capacity.
- Key Achievements:
- Successfully delivered 50+ product registrations across multiple jurisdictions, supporting business expansion and revenue continuity.
- Achieved 100% compliance in license renewals and regulatory submissions, eliminating regulatory downtime risk.
- Supported successful regulatory inspections and GMP audits with consistently favorable outcomes.
- Played a key role in enabling multi-country market expansion strategies through timely regulatory approvals.
- Recognized internal advisor for regulatory compliance, labeling, and product stewardship decisions.
Regulatory Affairs Administrator
CKL Africa Ltd
11.2018 - 06.2019
- Streamline review and submission of ACTD/CTD dossiers
- Coordinate full product lifecycle activities encompassing registration, renewal, variation, and regulatory updates to ensure seamless product availability across all markets.
- Facilitate GMP compliance programs, internal audits, and external inspection readiness, consistently securing favorable audit outcomes.
- review product labels, packaging, and artwork for compliance
- Streamline regulatory risk assessments, compliance reporting, and management reviews to support strategic decision-making and promote business continuity.
Quality Control Analyst
CKL Africa Ltd
06.2017 - 10.2018
- Conducted routine laboratory testing and quality control analysis of pharmaceutical and veterinary products.
- Supported quality assurance processes ensuring compliance with internal and regulatory standards.
- Contributed to documentation, reporting, and laboratory compliance activities.
Education
MSc - Environmental Chemistry
University of Nairobi
01-2022
Professional Diploma - Leadership
Shaw Academy (UK)
01-2018
B. Tech - Analytical Chemistry
Technical University of Mombasa
01-2016
Skills
- Regulatory Affairs Strategy & Leadership
- Multi-Country Product Registration (Africa & International Markets)
- ACTD/CTD Dossier Compilation & Submission
- Market Authorization & Product Lifecycle Management
- Regulatory Intelligence & Compliance Monitoring
- GMP, GDP & Quality Management Systems
- Regulatory Authority Engagement & Liaison
- Regulatory Risk Assessment & Mitigation
- Product Labeling & Packaging Compliance
- External Manufacturing (CMO/CRO) Coordination
- Regulatory Audits, Inspections & Readiness
- Cross-Functional Leadership (QA, Supply Chain, Commercial)
- License Management, Renewals & Variations
- ESG / Environmental Compliance Integration
Affiliations
- Technical Committee Member – Pharmaceutical & Alternative Medicines, KEBS (Apr 2026 – Present)
- Technical Committee Member – Occupational Health & Safety, KEBS (Apr 2026 – Present)
Timeline
Regulatory Affairs & EHS Manager
CKL Africa Ltd
07.2019 - Current
Regulatory Affairs Administrator
CKL Africa Ltd
11.2018 - 06.2019
Quality Control Analyst
CKL Africa Ltd
06.2017 - 10.2018
B. Tech - Analytical Chemistry
Technical University of Mombasa
Professional Diploma - Leadership
Shaw Academy (UK)
MSc - Environmental Chemistry
University of Nairobi
References
Available upon request.