Ms. Rosemary Nkemdilim Onwualu

Position: Assistant Director, Drug Evaluation and Research - National Agency for Food & Drug Administration and Control (NAFDAC)
Categories: RA Speakers 2023

Rosemary Nkemdilim Onwualu is a Scientist, GMP inspector, Lead Quality Auditor certified, and a regulatory Inspector with over 10 years in pharmaceutical GMP inspections and twenty three years’ experience with National Agency for Food and Drug Administration and Control [NAFDAC] Nigeria. Saddled with the responsibility to regulate medicinal products and medical devices. Rosemary is an experienced leader in the conduct of QMS internal auditing, inspection readiness activities, SOP development, quality document management, training, and technical paper reviews. She is recognized for her expertise in implementing QMS principles across settings and systems, a member of the quality team of her NRA, an active member of the NAFDAC-WHO GBT Team and has presented as subject matters topics regarding quality policy, quality objects, and other related matters.

She is the Nigerian Deputy GBT national focal person, that derived and championed the coordination and supervision of the Nigeria NRA GBT Program for Regulatory Inspection and Clinical Trial Oversight functions respectively to the successful attainment of maturity level three [ML3].

She contributed to several initiatives in terms of development of policy, guidance documents for Good Regulatory Practice in Nigeria.

A resource person in system strengthening programs, capacity building, training including mentoring of other NRAs on GBT Program in Nigeria and the Cote divoire for the attainment of ML3.

She participated in the review of WHO Listed Authority (WLA) guidance document.