Bibian Chinemerem
Regulatory Affairs and Product Manager
About
A result driven Regulatory Affairs and Product Management professional with over 9 years experience in pharmaceutical regulatory compliance, product lifecycle management, and market strategy development and execution. Proven track record of securing product approvals, optimizing regulatory timelines, and driving revenue growth through strategic product positioning. Strong background in Food Science & Technology with cross-functional expertise spanning regulatory, marketing, and quality systems.
Proficient at aligning compliance requirements with commercial objectives.
Experience
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.
Education
MSc - Food Quality Control and Assurance - Federal University of Agriculture, Abeokuta (2019-01 - 2025-01)
B.Sc - Food Science and Technology - University of Nigeria, Nsukka (2010-01 - 2014-12)
SSCE - NECO - Umuocham Girls' Secondary School (2000-01 - 2006-12)
