Iris Ampofo-Barnes Email & Phone Number

Dynamic, driven, and result-oriented Regulatory Affairs Professional with 25+ years of progressive leadership and management experience. Ability to expand beyond the scope of assigned responsibilities to deliver on business objectives and priorities. Proven track record of exceeding expectations and delivering quality products throughout the product.

Boston, Massachusetts, US

·Led regulatory compliance efforts for blood-drawn devices, overseeing 510(k) submissions and CE mark applications.·Collaborated with R&D, engineering, and quality teams to integrate regulatory requirements into product development, reducing development time by 20%.·Developed and implemented risk management strategies that decreased regulatory.

Brentford, Middlesex, GB

Managed regulatory strategy for GSKCH's Equity Brand portfolio, focusing on Motion Sickness and Smoking Cessation Aids.Secured over 45 regulatory approvals within a year, resulting in a 30% profit increase.Developed and implemented regulatory strategies that led to 67%-time savings in four years.Key Achievement:·Created systems for tracking over 150.

Basel, Baselstadt, CH

Led US and Global CMC regulatory strategy for development projects and marketed products.Managed product portfolios with multiple SKUs, ensuring seamless compliance and timely approvals.Developed compliance training programs and KPIs, reducing compliance-related errors by 35%. Key Achievement:·Received a BRAVO Impact Award for leadership in streamlining.

Basel, Baselstadt, CH

Led US CMC regulatory strategy for assigned development projects and marketed products and coordinated timely responses to FDA queries. Worked closely with US Business partners (Manufacturing, Operations, Quality, Product Development and 3rd Party sites) to ensure registration compliance to site documentations were aligned. Chosen as an integral team.

Basel, Baselstadt, CH

Led and executed Regulatory CMC strategy for new registrations, variations and renewals as related to analytical methods, stability and manufacturing & packaging changes for assigned globally managed products. Created and implemented a CMC Index template to point out important registered product information in an expeditious manner.

Led a staff of 4 in US region to restructure, organize and optimize support and focus on product development, contract manufacturers and clinical quality assurance needs. Supported product complaints, drug information requests, and provided responses to consumer inquiries. Directed CMC/GMP support for over 50 contract manufacturing and formulation.

Basking Ridge, NJ, US

Developed and maintained INDs, NDAs and other regulatory documentation for assigned brands and products. Managed Regulatory Compliance activities to ensure filed applications are in full compliance with FDA guidances and regulations. Performed due diligence visits of new and existing contractors to assess compliance with GxPs and Daiichi Quality standards..

Ensured completion of regulatory submissions in support of INDs, Bio-INDs, NDAs, and ANDAs. Crafted responses to FDA complete response letters. Supported product complaints, drug information requests, and provided responses to consumer inquiries. Developed collateral directory and implemented formulary submission outline to track criteria for drug product.