Regulatory Affairs Manager - Tyonex Nigeria Limited - Igando, Lagos State
(2021-01 - 2025-01)
- Developed and led regulatory strategy and secured approval for multiple pharmaceutical products through NAFDAC, reducing approval timelines by 40%
- Successfully Reviewed and submitted over 30 CTD dossiers, achieving screening and review clearance with NAFDAC.
- Managed end-to-end regulatory submissions for drugs, medical devices, cosmetics and supplements.
- Ensured 100% compliance of product artworks and labeling with NAFDAC regulations.
- Coordinated with manufacturers to obtain and validate required documentation, ensuring 100% dossier completeness prior to submission.
- Led regulatory communications and successfully resolved queries and compliance issues, avoiding delays in product approvals.
- Collaborated with cross-functional teams to align regulatory requirements with product development and commercialization plans.
- Developed corrective and preventive action plans (CAPA) following regulatory audit findings.
- Managed product life cycle documentation, including renewals, variation submissions, and post-approval changes in compliance with regulatory timelines.
- Successfully obtained approval for the company's new factory layout drawing.
Product Manager - Tyonex Nigeria Limited - Igando, Lagos State
(2023-01 - 2025-01)
- Expanded the company's product portfolio by successfully leading the launch of key products including Aviphage, Avinate (30mg, 60mg, 120mg), Bewell Amino Syrup, and Maxiday, among others products.
- Led end-to-end product lifecycle management; from market research and regulatory coordination to pricing strategy, go-to-market strategy, field execution and post-launch performance tracking.
- Drove substantial revenue growth, increasing the company's monthly inflow by over 150% through effective product positioning and demand generation.
- Designed and executed marketing strategies, using field insights, key opinion leader (KOL) engagement, and channel expansion to maximize product uptake and brand visibility
- Collaborated closely with sales teams, delivering targeted marketing support that contributed to achievement of sales targets.
- Planned and implemented marketing campaigns, increasing brand awareness and product visibility.
- Conducted market research and competitive analysis to identify growth opportunities and strengthen brand positioning.
- Designed and developed promotional materials (detail aids, flyers, brand reminders) to enhance product communication and field effectiveness.
- Managed product packaging development, aligning branding with market needs and regulatory expectations.
- Monitored campaign performance and strategies implementation and provided data-driven reports to management for strategic decision-making.
- Trained and aligned sales teams on product knowledge and brand strategies to ensure consistent execution in the field.
Regulatory Affairs Officer - Olpharm Nigeria Ltd - Opebi, Ikeja, Lagos State
(2017-01 - 2020-12)
- Successfully handled product registrations and renewals with NAFDAC.
- Reviewed and compiled regulatory dossiers ensuring full compliance before submission.
- Managed registration and renewal of pharmaceutical product licenses, achieving timely approvals for multiple products annually.
- Reviewed and validated regulatory dossiers, ensuring compliance with NAFDAC submission requirements.
- Improved approval efficiency by consistently following up with NAFDAC and addressing regulatory queries promptly.
- Reviewed and approved product labeling, ensuring strict compliance with regulatory guidelines.
- Prepared and submitted shipping documentation for regulatory endorsement, facilitating smooth product clearance at ports.
- Ensured timely renewal of annual pharmacist and premises license with appropriate authorities.
- Reduced documentation errors and improved approval success rate
Laboratory Analyst (Internship) - NAFDAC Zonal Laboratory - Agulu, Anambra State
(2013-04 - 2013-09)
- Conducted chemical and microbiological analysis on food and water for Registration and compliance purposes
- Conducted mycotoxin and melamine analysis on cereals and dairy products respectively for compliance purposes.
- Identified and quantified Active Pharmaceutical Ingredients in drugs for compliance purposes.
- Prepared laboratory reagents and media for laboratory analysis.
