Experienced Regulatory Affairs Manager known for driving regulatory compliance and streamlining approval processes. Delivered strategic oversight that led to reduced approval times and enhanced market access. Always focused on fostering strong relationships with regulatory bodies and internal teams to ensure seamless project execution.
Overview
18
18
years of professional experience
4
4
Certificates
11
11
years of post-secondary education
Work History
Regulatory and Government Affairs Consultant
Self Employed Services
Lagos, Nigeria
06.2024 - 12.2025
Dossier compilation, Analysis and Vetting to ensure correctness and alignment with proposed application
Conducted thorough market research to identify potential growth opportunities.
Devised detailed project plans with clear milestones, encouraging team focus and direction.
Recommended improvements on business processes for optimised performance and profitability.
Pharmaceutical label management to ensure that drugs are labelled accurately and up to date to meet regulatory requirements while ensuring patient safety
Developed comprehensive business strategies to deliver client objectives.
Assessed risks associated with proposed business solutions, minimising potential issues.
Enhanced client understanding of market trends, leading to informed decision making.
Collaborated with a variety of industry professionals for effective project delivery.
Identified deviations from standard operating procedures, understanding causes and preventing reoccurrence .
Guided clients toward improved organisational structures and better solutions for identified problems.
Conducted studies focused on analysing current strategies and evaluating feasibility and potential results of proposals.
Located deviations from standard operating procedures, understanding causes and preventing reoccurrence.
Drafted procedure manuals, work definitions and standard operating procedures by job title or work area.
Applied data toward developing optimum objectives, strategies and plans for regulatory activities.
Regulatory affairs manager
AstraZeneca Nigeria Ltd
Lagos, Nigeria
01.2010 - 05.2024
Ensured up-to-date knowledge of regulatory developments, quickly communicating necessary process changes to maintain compliance.
Optimised product development timelines by integrating regulatory considerations early on.
Reviewed marketing materials for compliance with advertising regulations protecting the company against legal implications.
Developed standard operating procedures to streamline routine tasks and improve productivity.
Prepared and maintained supporting regulatory documentation, including product literature and technical reports, conveying scientific information clearly and logically to ensure comprehension.
Trained new employees effectively reducing their learning curve and increasing productivity sooner than usual.
Improved interdepartmental communication channels which enhanced overall workflow efficiency.
Achieved regulatory compliance by meticulously reviewing product labels and packaging.
Ensured adherence to industry standards, resulting in minimal non-compliance issues.
Communicated and negotiated effectively with cross-functional internal and external stakeholders for optimised project outcomes.
Devised comprehensive strategies that resulted in expedited approval from health authorities.
Provided advisory support during audits; resulted in fewer discrepancies noted by auditors.
Proactively identified potential risks, thus reducing instances of non-compliance.
Managed timely submissions of quality reports, maintaining good standing with regulators.
Coordinated with departments for seamless execution of regulatory strategies.
Maintained up-to-date knowledge on relevant legislation, ensuring business operations remained compliant at all times.
Maintained up to date knowledge on regulatory changes to ensure consistent compliance in country of sale.
Collaborated with international teams for effective management of global projects.
Led negotiations with authorities, achieving favourable outcomes for the company.
Owned various general administrative duties to strict timelines.
Investigated suspicious, irregular or non-regulatory compliant activities.
Recorded and actioned findings of internal investigations in line with proper procedure.
Liaised with multi-disciplinary staff to collect and process data quickly.
Supported creation of training materials to educate employees on regulations and impact of non-compliance.
Ensured company policies were implemented and adhered to.
Conducted intensive audits and risk assessments to identify and minimise non-compliance.
Supported company ethos of continual improvement and growth with stringent audit schedule.
Protected against fines and reputational damage caused by potential non-compliance.
MEDICAL REPRESENTATIVE (SPECIALTY CARE)
AstraZeneca Nigeria Ltd
12.2008 - 01.2010
New market penetration by introducing and establishing the use of AstraZeneca's oncology portfolio products at key teaching hospitals in the western part of Nigeria
Developed doctors from being ordinary prescribers to key opinion leaders for AstraZeneca through good interpersonal skills and the maintenance of relationships with the key decision makers at the hospitals
Liaise with healthcare professionals to ensure prescription generation of Oncology products
Made regular presentations to healthcare professionals to improve their product knowledge
Liaise with our distributors to ensure that orders from our customers are all attended to
Weekly follow-up on specialists to ensure new patients are with AstraZeneca's oncology products
Work with the sales team to develop strategies to approach potential customers
Stay up to date with the latest clinical data, and pass this information on to healthcare professionals at presentations
Discovering New Markets for AstraZeneca Products
HOSPITAL PHARMACIST
Lagos State University Teaching Hospital (LASUTH)
Ikeja
07.2008 - 12.2008
Performed ward rounds to take patient drug histories and collect up-to-date information.
Provided medication information to patients, improving their understanding of drug use and potential side effects.
Advised on most appropriate form of medication based on effectiveness and patient preference.
Vetted all doctor prescriptions before dispensing medication to reduce errors.
Responded to queries regarding dosages, indications and drug availability, communicating clearly with patients from range of backgrounds.
Collaborated with multidisciplinary healthcare professionals, enhancing patient care.
Enhanced quality assurance by conducting regular checks on pharmaceutical stock.
Kept up-to-date with latest pharmacy best practices, maintaining professional competency.
Directed technical support staff, verifying accurate documentation of dispensed medication.
Monitored pharmacy inventory, promptly reordering low-stock supplies to prevent stock-outs.
Facilitated staff training sessions on updated pharmacy guidelines and new medications.
Community Pharmacist
Rinofel Pharmacy
Ogba, Lagos, Nigeria
04.2008 - 07.2008
Assisted patients in managing chronic illnesses, ensuring better health outcomes.
Streamlined operational processes within the pharmacy for improved productivity.
Implemented new dispensing systems to increase accuracy.
Improved patient understanding of medications by providing detailed explanations.
Ensured legal compliance in all pharmaceutical practices within the pharmacy.
Promoted healthy lifestyles through preventative measures and education initiatives.
Managed a team of pharmacy assistants for efficient workflow.
Increased adherence to medication regimens with regular consultations.
Conducted routine stock checks to avoid supply shortages.
Adhered to strict data confidentiality practices to safeguard patient information.
Managed pharmacy budgets through inventory management.
Maintained accurate and detailed records of all medications processed through pharmacy.
Applied therapeutics knowledge and skills, enabling patients to receive safe and effective medication.
Advised patients on pharmaceutical products and potential side effects for medications.
Education
Master of Science - Pharmaceutical Technology and Medicines Control
University of Bradford
Bradford/ United Kingdom
01.2025 -
Certification - Regulatory Compliance
University of Pennsylvania
United states of America
09.2024 - 12.2024
Master of Business Administration - Marketing
Obafemi Awolowo University
ile Ife/Nigeria
04.2013 - 10.2016
Bachelor of Pharmacy - Pharmacy
Obafemi Awolowo University
ile ife/ Nigeria
09.1998 - 12.2005
Skills
Legal Knowledge
undefined
Certification
Compliance
Languages
English
Fluent
French
Advanced
Yoruba
Fluent
Timeline
Master of Science - Pharmaceutical Technology and Medicines Control
University of Bradford
01.2025 -
Certification - Regulatory Compliance
University of Pennsylvania
09.2024 - 12.2024
Regulatory and Government Affairs Consultant
Self Employed Services
06.2024 - 12.2025
Master of Business Administration - Marketing
Obafemi Awolowo University
04.2013 - 10.2016
Regulatory affairs manager
AstraZeneca Nigeria Ltd
01.2010 - 05.2024
MEDICAL REPRESENTATIVE (SPECIALTY CARE)
AstraZeneca Nigeria Ltd
12.2008 - 01.2010
HOSPITAL PHARMACIST
Lagos State University Teaching Hospital (LASUTH)
07.2008 - 12.2008
Community Pharmacist
Rinofel Pharmacy
04.2008 - 07.2008
Bachelor of Pharmacy - Pharmacy
Obafemi Awolowo University
09.1998 - 12.2005
Personal Information
Female
Age: 43
Awards
Catalyze Award ‘We Play to Win’, 04/2021
Catalyze Award ‘Becoming a Strong Regulatory Pacesetter’, 06/2021
Nomination for African Cluster Everyday Excellence ‘Be Discipline’, 06/2021
International Regulatory Award ‘We Play to Win’, 07/2021
Catalyze Award ‘Acceleration of Product License Approvals for Nigeria’, 07/2021
3rd Best Overall in Product Knowledge, AstraZeneca Sub Sahara African (SSA) Conference, 02/2009
Award for Excellence, National Youth Service Corps (NYSC), Zamfara State, 2007
Activities
Fashion
Make up
Good dress sense
Personal Information
Age: 43
Awards
Catalyze Award ‘We Play to Win’, 04/2021
Catalyze Award ‘Becoming a Strong Regulatory Pacesetter’, 06/2021
Nomination for African Cluster Everyday Excellence ‘Be Discipline’, 06/2021
International Regulatory Award ‘We Play to Win’, 07/2021
Catalyze Award ‘Acceleration of Product License Approvals for Nigeria’, 07/2021
3rd Best Overall in Product Knowledge, AstraZeneca Sub Sahara African (SSA) Conference, 02/2009
Award for Excellence, National Youth Service Corps (NYSC), Zamfara State, 2007