YUSUF ONUCHE WILLIAMS
Regulatory Affairs Manager | Pharmaceutical Compliance Expert
Oworoshoki, NG.About
Highly accomplished Regulatory Affairs Manager with over a decade of experience in the pharmaceutical industry, specializing in NAFDAC compliance, import/export documentation, and product registration. Proven expertise in managing complex regulatory processes, developing Common Technical Documents (CTDs), and ensuring seamless market authorization for new and renewed drugs. Adept at cross-functional collaboration, risk management, and leveraging strong analytical and leadership skills to maintain stringent regulatory adherence and drive business continuity.
Work
MeCure Pharmaceuticals
|Asst. Regulatory Affairs Manager
Oshodi, Lagos, Nigeria
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Summary
Currently leading regulatory affairs operations, managing complex import documentation and ensuring compliance for pharmaceutical products at MeCure Pharmaceuticals.
Highlights
Streamlined import permit processes for APIs, narcotics, diagnostics, and excipients, ensuring timely approval and compliance with NAFDAC regulations.
Managed the collation and development of Common Technical Documents (CTDs) for new and renewed drug marketing authorizations, accelerating market entry.
Expedited NAFDAC stamping for product, packaging, and raw material imports through the PIDCARMS portal, ensuring smooth customs processes.
Supported successful registration and renewal of drugs via the NAFDAC NAPAMS portal, maintaining product portfolio compliance.
Developed clear, compliant product labels and patient information leaflets, enhancing user safety and regulatory adherence.
MeCure Pharmaceuticals
|Regulatory Affairs Executive
Oshodi, Lagos, Nigeria
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Summary
Managed regulatory compliance and documentation efforts for pharmaceutical products, ensuring adherence to national and international standards.
Highlights
Maintained comprehensive knowledge of evolving domestic and international pharmaceutical regulations, ensuring proactive compliance.
Oversaw documentation efforts, ensuring 100% compliance with domestic and international regulatory standards for all products.
Successfully obtained required licenses, permits, and certificates from regulatory agencies, facilitating uninterrupted business operations.
Communicated complex regulatory information across multiple departments, ensuring accurate interpretation and application of guidelines.
Collaborated with product teams to integrate regulatory requirements into development and launch processes.
Independent National Electoral Commission
|Assistant. Reg. Officer
Atisbo, Oyo, Nigeria
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Summary
Managed voter registration and electoral processes for specific units, ensuring accurate record-keeping and smooth election operations.
Highlights
Registered adult residents in Unit 04, Ward 003, Irawo Owode, Atisbo L.G.A., contributing to civic participation.
Processed and issued temporary voter cards to registered electors, enhancing accessibility for eligible residents.
Supervised the electoral process in Unit 03, Ward 006, Alaga, Atisbo L.G.A., ensuring fair and transparent conduct.
Nigeria Police Medical Services
|Laboratory Assistant
Falomo, Lagos, Nigeria
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Summary
Performed a range of laboratory procedures and analyses, ensuring accurate diagnostic results and maintaining equipment calibration.
Highlights
Performed diverse lab procedures including phlebotomy, coagulation profiles, blood typing, serological studies, and routine cultures, supporting accurate patient diagnostics.
Monitored ongoing tests and experiments, meticulously documenting deviations to ensure data integrity.
Prepared and maintained laboratory equipment for research experiments, ensuring operational readiness and precision.
Confirmed accuracy of test results and reported findings to medical pathologists and physicians, contributing to informed medical decisions.
Analyzed human fluid samples and calibrated analytical equipment, maintaining high standards of data reliability and operational efficiency.
Education
Kogi State University
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BSc
Biochemistry
Ochaja Boys Sci. Sec. Sch
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SSCE/WAEC
Science
Languages
English
Igala
Certificates
NAFDAC-Ports Inspection data capture and risk management system PIDCARMS
Issued By
NAFDAC
Utiva Product Management
Issued By
The UTIVA Product School
Utiva Data Analytics with Python
Issued By
The UTIVA Data School
The Fundamentals of Digital Marketing
Issued By
Google Digital Skills for Africa
NIM Proficiency Certificate in Management
Issued By
The Nigeria Institute of Management
Skills
Regulatory Affairs & Compliance
NAFDAC Regulations, Import/Export Documentation, Common Technical Documents (CTD), Regulatory Inspections, Product Registration, Licensing & Permits, Compliance Management, Risk Management, NAFDAC PIDCARMS Portal, NAFDAC NAPAMS Portal.
Project Management & Methodologies
Scrum, Agile, Project Delivery, Goal-Orientation, Proactivity, Strategic Planning.
Communication & Collaboration
Effective Communication, Collaboration Skills, Persuasion, Ideation Leadership, Cross-functional Collaboration.
Data & Technical Tools
Microsoft Productivity Tools, Data Analytics, Python, User Research, Digital Marketing.
Laboratory Operations
Phlebotomy, Coagulation Profile, Blood Type Analysis, Serological Studies, Routine Cultures, Prenatal Blood Tests, PCV, WBC, FBS, Equipment Calibration, Sample Analysis.