Bolanle Aladegbola
Southall
Summary
I am a results-driven senior regulatory affairs manager with extensive experience in ensuring compliance, streamlining regulatory processes, and managing global submissions. Skilled in developing regulatory strategies, interpreting complex regulations, and collaborating cross-functionally to support product approvals and market expansion. Adept at leading teams, driving operational efficiency, and maintaining strong relationships with health authorities. Passionate about innovation and continuous improvement in regulatory affairs. Proven ability to navigate evolving regulatory landscapes while ensuring business success.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Trainee Pharmacist
Day Lewis Pharmacy
10.2023 - 01.2025
- Accurately dispensed various medicines, enhancing patient safety and satisfaction
- Conducts patient consultations, improving health outcomes and adherence.
- Manages inventory effectively, reducing waste and ensuring availability.
- Collaborates with team, fostering a supportive and efficient work environment.
- Communicates effectively, promoting safe medication use and continuous improvement.
- Manage prescription processing and patient consultations while learning advanced pharmaceutical protocols and regulatory compliance standards
Regulatory Affairs Lead - Sub-Sahara Africa
Reckitt
06.2021 - 09.2022
- Streamlined the submission and approval business process for MAAs, NDAs, and RTQs, achieving a 30% faster approval rate across six countries. This involved rigorous Process Review and KPI tracking, resulting in 15 improved regulatory submissions and successful regulatory Projects.
- Developed and executed strategic regulatory plans to support product lifecycle management.
- Led compliance initiatives, ensuring alignment with local and global regulations.
- Managed regulatory interactions with Ghana, Kenya and Côte d'Ivoire authorities, including regular meetings, ensuring timely approvals.
- Led CMC regulatory input for post-approval variations, including updates to SmPCs and Patient Information Leaflets, and market authorization maintenance, ensuring compliance with ICH guidelines.
- Managed the submission and maintenance of all regulatory materials, including SmPCs, Patient Information Leaflets, and RMPs, ensuring compliance with local regulations.
- Successfully managed 5 batch release issues, ensuring timely resolution and minimizing disruption to product supply.
- Served as the primary regulatory advisor for business units, commercial teams, and cross-functional stakeholders.
- Developed and delivered compliance training programs based on training needs analysis, improving team efficiency by 25% and ensuring regulatory adherence.
- Established key Performance Measurement metrics to track the effectiveness of regulatory training programs, resulting in 20% improvement in team performance.
- Developed and implemented a comprehensive onboarding program for new regulatory affairs team members, resulting in 20% faster time to productivity.
Regulatory Affairs Lead - West Africa
Reckitt
07.2014 - 06.2021
- Developed and implemented Global CMC regulatory strategies for three countries, focusing on life-cycle maintenance and improving approval rates and time-to-market efficiency by 20%.
- Partnered with PDM to manage filings for over 20 new products within the region, optimizing regulatory processes and reducing review times by 30%, including securing Scientific Advice meetings with various regional HAs.
- Spearheaded the transition to electronic dossier management systems, implementing robust version control for all work processes and ensuring GxP compliance, preparing for and successfully completing HA inspections.
- Developed and maintained an E2E Knowledge Management system for regulatory partnerships with internal and external stakeholders, including collaboration with Subject-Matter Experts (SMEs).
- Ensured successful execution of product registrations, renewals, and post-marketing compliance requirements, including oversight of publishing regulatory documents.
- Developed and implemented quality assurance and quality control processes, ensuring GxP compliance and inspection readiness, improving efficiency and reducing response times by 25%.
- Developed and implemented standard operating procedures (SOPs) that were aligned with current regulatory requirements, QMS guidelines, and corporate governance, managing all change requests through the established process. Successfully managed SOPs within the electronic system, ensuring compliance with all regulatory requirements.
- Developed and implemented standard operating procedures (SOPs) using instructional design principles and learning content development best practices, ensuring compliance with all regulatory requirements and QMS guidelines.
- Led regulatory strategy and compliance initiatives for pharmaceutical products, ensuring adherence to international standards and streamlining approval processes.
- Managed submission documentation for drug applications across multiple markets, coordinating with cross-functional teams to maintain quality standards.
- Orchestrated regulatory submissions for key pharmaceutical products, reducing approval timelines through effective stakeholder management.
- Developed and maintained relationships with health authorities, facilitating smooth communication channels and enhancing submission success rates.
- Implemented new regulatory tracking systems and procedures, optimising workflow efficiency and improving documentation accuracy.
Drug Regulatory Affairs Manager
Sandoz Pharma
11.2013 - 06.2014
- Led regulatory strategy and compliance initiatives for pharmaceutical products, ensuring adherence to international standards and streamlining approval processes
- Managed submission documentation for drug applications across multiple markets, optimizing submission processes and coordinating with cross-functional teams to maintain quality standards
- Orchestrated regulatory submissions for key pharmaceutical products, reducing approval timelines through effective stakeholder management
- Developed and maintained relationships with health authorities, facilitating smooth communication channels and enhancing submission success rates
- Implemented new regulatory tracking systems and procedures, optimising workflow efficiency and improving documentation accuracy
Regulatory Affairs Manager
GlaxoSmithKline Pharma Nigeria Limited
09.2011 - 10.2013
- Database Management: Performed routine audits and updates within the OPAL regulatory database to maintain accuracy and compliance.
- Continuous Learning: Established a framework for adapting to regulatory updates and new scientific developments.
- Led regulatory compliance initiatives and managed product registrations across Nigeria, ensuring adherence to local pharmaceutical regulations and standards.
- Streamlined documentation processes and maintained comprehensive regulatory dossiers for pharmaceutical products, reducing approval timelines.
- Partnered with cross-functional teams to develop regulatory strategies, facilitate product launches, and ensure compliance with regional requirements.
- Orchestrated successful registration of key pharmaceutical products, strengthening market presence while maintaining strict quality standards.
- Spearheaded regulatory compliance strategies across West African markets, managing product registrations and ensuring adherence to pharmaceutical standards.
- Pharmacovigilance: Collaborated with the medical unit to collect, collate and submit pharmacovigilance reports received for products manufactured by GSK whether on sale (or not) or on trials.
Education
Masters - Pharmacy (OSPAP)
University of Brighton
10.2023
Masters - Project Development & Implementation (Minor in Sociology)
University of Ibadan
10.2008
Bachelor - Pharmacy
University of Ibadan
02.1999
Skills
- Team Leadership
- Process Improvement
- Strategic Planning
- Risk Assessment
- Project Management
- Training & Development
- System Regulatory Expertise
Websites
Certification
- Medical Device Regulation 2017/745 EU regulatory affairs.
- Regulatory Medical Writing Basics Certificate Course In Drug Regulatory Affairs.
- Good Clinical Practice (GCP) Introduction.
- Introduction To GCP - IMP Management.
Languages
English
Additional Contact
- Ms Hiral Patel. Day Lewis Pharmacy, Mill Hill, 07921067724
- Dr Oladapo Babatola Samphire Ward Chatterton House, 07889993029
Hobbies and Interests
I love reading books especially those based on real historical events.
Affiliations
- Regulatory Affairs Professional Society
Timeline
Trainee Pharmacist
Day Lewis Pharmacy
10.2023 - 01.2025
Regulatory Affairs Lead - Sub-Sahara Africa
Reckitt
06.2021 - 09.2022
Regulatory Affairs Lead - West Africa
Reckitt
07.2014 - 06.2021
Drug Regulatory Affairs Manager
Sandoz Pharma
11.2013 - 06.2014
Regulatory Affairs Manager
GlaxoSmithKline Pharma Nigeria Limited
09.2011 - 10.2013
Masters - Project Development & Implementation (Minor in Sociology)
University of Ibadan
Bachelor - Pharmacy
University of Ibadan
Masters - Pharmacy (OSPAP)
University of Brighton
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