Jackline Ngugi

1. Optimized reaction conditions and buffer chemistry to improve small RNA capture within an existing protocol. 2. Modified an RNA seq workflow for combined long- and small-RNA library preparation within a single workflow. 3. Maintained structured experimental documentation and research records in a laboratory management system to ensure traceability and data integrity.

1. Supported regulatory strategy and submissions for the registration of 10 pharmaceutical products in partnership with Dr. Reddy's Laboratories, liaising directly with national regulatory authorities. 2. Coordinated the setup of a GMP-compliant cold-chain distribution facility, aligning engineering, quality, legal, and design functions to achieve regulatory and operational readiness. 3. Secured 20+ import permits for registration samples and commercial medicines, ensuring continuity of supply.

1. Prepared, reviewed, and submitted regulatory dossiers for 15 pharmaceutical products, 10 medical devices, and 20+ food supplements, ensuring compliance. 2. Coordinated regulatory submissions and authority queries across East Africa, India, and China, maintaining compliant, on-time approval processes. 3. Conducted regulatory intelligence on evolving regulations, translating requirements into practical guidance and GxP training for cross-functional teams, including warehouse and logistics staff.

1. Led regulatory activities for 30+ pharmaceutical products, including CTD dossier preparation, variations, and retention applications across the full product lifecycle. 2. Developed and maintained SOPs 3. Led quality investigations and CAPA implementation with manufacturing partners, resolving product quality issues and strengthening pharmacovigilance oversight. 4. Conducted literature reviews and delivered scientific/medical training (CME) to commercial teams and healthcare professionals

Biopharmaceuticals, Biopharmaceutical Analysis, Genetics, Biomedical and Statistical Data Science, Scientific Data Management and Visualization, Good Manufacturing Practice (GMP), Regulatory Affairs, Bioprocess Engineering, Project and Process Management.