Pauline EJOVWOKE AGBROKO
London,Greater London
Summary
Experienced Regulatory Officer with over 10 years in public health, regulatory affairs and quality assurance. Expertise in assessing quality, safety and efficacy of medicines, cosmetics and medical devices, ensuring compliance with Good Manufacturing Practice (GMP) standards. Proficient in monitoring compliance through document control and audits of FDA regulations and Standard Operating Procedures (SOP), aiming to leverage technical knowledge to drive positive regulatory change.
Overview
1
1
Certification
26
26
years of professional experience
Work History
Chief Regulatory Officer - Drug Evaluation and Research Directorate
National Agency for Food and Drug Administration and Control
Lagos
11.2013 - Current
- Collaborated with marketing authorization holders, health facilities, private organisations, and contract research organisations to establish regulatory systems ensuring quality control of cosmetics and medical devices throughout their lifecycle.
- Conduct reviews and analyze applications demanding registration and authorization of cosmetics and medical device to the registration commission.
- Adhere to Regulatory Compliance by ensuring that the law and regulations related to licensing, registration, quality control and sales of cosmetics products are to the satisfaction of the consumers.
- Compiled specifications, guidelines, and regulations for production, importation, exportation, registration, distribution, and sale of cosmetics products to streamline compliance processes.
- Granting permit for the importation or manufacture of a sample of drug, drug product, cosmetic or medical device for the purpose of registration or clinical trial, and the importation or manufacture shall be in accordance with the conditions specified in the respective permit.
- Conduct GMP Inspection of facilities where cosmetics and medical devices products are manufactured sold or distributed in accordance to relevant guiding procedures and NAFDAC regulations.
- Preparing Inspection reports within 5-7 days and recommend registration or otherwise of cosmetics product's and the eligibility of the facility for GMP certificate ensuring adequate regulatory actions are implemented as at when due.
- Conducted research in clinical trials within regulatory affairs, focusing on new combination drug products, dosage schedules, and drug delivery systems, leveraging problem-solving and communication skills to facilitate effective outcomes.
- Carried out sampling of cosmetics and medical devices products after confirming satisfactory GMP status for submission to the laboratory service directorate.
- Coordinating and Collating Monthly Reports of all activities conducted in Cosmetics and Medical Devices Division.
- Participate in the development of Standard Operating Procedures (SOP) for cosmetics and medical devices activities.
- Participate in Cosmetics and Medical Devices Quality Management Systems Audits (and corrective action if any) for all internal processes.
- Foster cooperation with regional and international bodies in pursuance of the vision of the Food and Drug Administration.
- Lagos, Cosmetics & Medical Device Division.
Program Officer (Monitoring and Evaluation)
Partners for Development
Maitama District
05.2008 - 05.2013
- Developed and implemented key performance indicators for monitoring and evaluating program progress, gathering baseline data and designing impact assessments to inform decision-making.
- Coordinated the design and implementation of HIV/AIDS healthcare components in field-level projects and provided technical assistance in reproductive healthcare capacity building to field programs.
- Worked with implementing partners, community-based organizations, Local Government Authorities, and Stakeholders to facilitate the implementation of monthly data collection on HIV/AIDS response through the use of the national reporting system NNRIMS.
- Provided technical support to partners and implemented on-the-spot skills building and data quality validation with a primary focus on HIV/AIDS and Tuberculosis components.
- Coordinated verification meetings with partners and stakeholders, facilitating discussions on policies, data collection methods, comparative data analysis, and feedback on implementation processes.
- Coordinated M&E step-down training activities on HIV/AIDS, enhancing capacity at national and local levels.
- Collaborated with and supported the Federal Ministry of Health (FMOH) and key partners to promote inform and build support for HIV clients.
- A project funded through the President's Emergency Plan for AIDS Relief - PEPFAR.
Senior Health Technical Officer
National Blood Service
Bristol
10.2007 - 03.2008
- Performed a range of scientific and technical activities related to blood (and where appropriate tissue) donations from our donors, with the support of the team.
- Managed blood bags and laboratory equipment for sample processing, ensuring adherence to safety and quality standards.
- Prepared samples for testing or storage, performed analytical tests, and maintained equipment to ensure operational readiness.
- Undertook precise repetitive manipulation of equipment and blood samples/donations and carried out routine tasks regularly.
- Handled queries from departments, medical staff, or visitors and trained support staff to enhance team capabilities.
Health Care Assistant
Livability-John Grooms Association
Borehamwood
09.2005 - 09.2007
- Provided personal care and support for people with physical, neurological, and learning disabilities.
- Worked under the supervision of qualified healthcare professionals and provided first-hand care, comfort, and safety to patients.
- Monitored client health conditions throughout care sessions to ensure timely interventions.
- Conducted clinical duties, including carrying out, monitoring, and recording results of medical tests for healthcare professional analysis.
- Took the temperature, blood pressure, and blood glucose levels of patients and recorded results.
- Enhanced patient mobility by supporting weight, turning patients, and assisting with heavy medical equipment.
- Set up equipment required by healthcare Professionals.
- Ensured supplies and medical equipment were replenished.
- Transported the client to medical appointments and helped them to run errands.
Health Care Assistant
Celia Johnson Court
Borehamwood
03.2004 - 08.2005
- Supported clients with personal care, meal assistance, and errands to promote independence and well-being.
- Supervised clients during personal hygiene activities, including washing, dressing, grooming, and toileting.
- Delivered personalised care and support to elderly clients, ensuring safety and comfort in daily activities.
- Monitored patients' conditions by taking temperatures, pulse, respirations, and weight.
- Assisted clients to attend appointments and monitored clients' health conditions.
- Provided emotional support to patients, fostering a comforting environment that enhanced their overall experience.
- Reporting client Progress and any concerns to the Home Care Manager.
Quality Control Officer
Nigerian Breweries Plc
Iganmu
12.2000 - 01.2004
Education
Master of Science - Pharmacology
University of Hertfordshire
Hatfield, United Kingdom01-2006
Bachelor of Science - Microbiology
University of Benin
Edo State, Nigeria01-1999
Skills
- Regulatory Strategy
- Compliance Oversight
- Public Health Policy
- Standard Operating Procedures
- Data Analysis
- Evidence collection
- Process Improvement
- Strategic Planning
- Regulatory Training
- Regulatory Innovation
- Collaboration
- Critical Thinking
- Time Management
- Schedule Management
- Communication
- Microsoft Office
- Enthusiastic
Certification
- Good Manufacturing Practices, African Union Development Agency (AUDA-NEPAD) Continental, 2023-01-01
- U.S. Food & Drug Administration Certificate of Attendance Understanding FDA Inspections and Data Webinar, U.S. Food & Drug Administration, 2023-01-01
- Fundamentals of Knowledge Managements, MODZ.UK Health Solutions Ltd, 2021-01-01
- Good Manufacturing Practice (GMP) Training Level One, National Agency for Food and Drug Administration and Control (NAFDAC), 2017-06-12
- Promoting the Quality of Medicines Certificate of Completion in Advanced GMP Training, United States Pharmacopeia, 2016-12-02
- Promoting the Quality of Medicines Certificate of Completion Introduction to Validation and Qualification, USAID/United States Pharmacopeia, 2016-01-26
- Good Manufacturing Practice Training, National Agency for Food and Drug Administration and Control (NAFDAC) & Pharmaceutical Manufacturing Group of Manufacturers Association of Nigeria, 2015-01-01
- Basic Good Manufacturing Practice Training, National Agency for Food and Drug Administration and Control (NAFDAC) & Pharmaceutical Manufacturing Group of Manufacturers Association of Nigeria, 2015-05-11
- Quality Assurance in HIV Counseling and Testing Workshop, Institute for Human Virology Comprehensive ART training, 2009-01-01
- Monitoring and Evaluation Workshop for Orphans and Vulnerable Children, Children of Hope Project, 2009-01-01
- Comprehensive family planning training, Partners for Development, 2009-01-01
- Cluster of differentiation CD4 courses a regimen in clinical Management of HIV/AID, Centre for Disease, 2008-01-01
- Good Laboratory Practice, HIV serology, CD4 and Chemistry in the clinical management of HIV/AIDS conducted, Institute of Human Virology, 2008-01-01
Custom
- Public Health Policy
- Standard Operating Procedures
- Data Analysis/ Ms. Office Suites
- Sample and Evidence Collection
- Goal oriented
- Motivated/Proactive
- Process Improvement
- Collaboration/Teachability
- Creativity/Critical Thinking
- Time/ Schedule Management
- Communication
- Enthusiastic
Timeline
Chief Regulatory Officer - Drug Evaluation and Research Directorate
National Agency for Food and Drug Administration and Control
11.2013 - Current
Program Officer (Monitoring and Evaluation)
Partners for Development
05.2008 - 05.2013
Senior Health Technical Officer
National Blood Service
10.2007 - 03.2008
Health Care Assistant
Livability-John Grooms Association
09.2005 - 09.2007
Health Care Assistant
Celia Johnson Court
03.2004 - 08.2005
Quality Control Officer
Nigerian Breweries Plc
12.2000 - 01.2004
Master of Science - Pharmacology
University of Hertfordshire
Bachelor of Science - Microbiology
University of Benin