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

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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

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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

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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

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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

Anyigba, Kogi State, Nigeria
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BSc Biochemistry

Ochaja Boys Sci. Sec. Sch

Ochaja, Kogi State, Nigeria
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SSCE/WAEC Science

Languages

English

Igala

Certificates

NAFDAC-Ports Inspection data capture and risk management system PIDCARMS

NAFDAC

Utiva Product Management

The UTIVA Product School

Utiva Data Analytics with Python

The UTIVA Data School

The Fundamentals of Digital Marketing

Google Digital Skills for Africa

NIM Proficiency Certificate in Management

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.