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 lifecycle. Extensive experience in product categories such as OTC Monograph Drugs, NDAs, ANDAs, and Cosmetics and Dietary Supplements. Proficiencies in Chemistry Manufacturing Controls (CMC), Clinical, Regulatory & Labeling compliance and Advertising and Promotional. Successful track record in motivating staff members to strive for flawless execution of tasks even in the midst of constant changes.

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 challenges.Key Achievement:·Successfully expanded the company's global presence, increasing projected revenue by 30% through strategic international market access.

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 regulatory submissions, resulting in a 25% monthly time savings.Delivered on business objectives and priorities. 100% Remote. Demonstrated track record of exceeding expectations and delivering quality products throughout the product lifecycle. Extensive experience in product categories such as OTC Monograph Drugs, NDAs, ANDAs, and Cosmetics and Dietary Supplements. Demonstrated proficiencies in Chemistry Manufacturing Controls (CMC), Regulatory & Labeling compliance and Advertising and Promotional.

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 project processes and reducing compliance gaps.Accepted this role as Regulatory Generalist to expand and broaden my overall Regulatory knowledge in the areas of advertising and promotion reviews and to strengthen my knowledge in strategizing beyond CMC. Manage diverse Equity Brand portfolio for the US Market which includes therapeutic areas of Motion Sickness, Smoking Cessation Aids, Antifungal (topical and vaginal), Analgesic, Allergy, Stimulant Laxatives and Cosmetics. Collaborate with cross-functional teams to provide regulatory guidance for the development and implementation of product labeling, claim substantiation. Provide advice for regulatory submissions strategies. Provide Regulatory reviews for various advertising and promotional materials to drive and support consumer facing content. Monitor global regulatory developments through participation in industry associations, newsletters, government websites and other resources. Proactively communicate significant issues to management.

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 member in the creation of a robust labeling process for the US organization to ensure 100% accuracy of all US labels.

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 products. Managed, coordinated and supported regulatory submissions (i.e. IND, Bio-IND, NDA, ANDA and responses to FDA deficiency letters).

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. Compiled and submitted post approval submission related supplements and annual reports. Provided CMC evaluations for potential changes as requested and follow up to ensure regulatory compliance including completion of change control records.

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 inclusion (e.g. clinical history, bioequivalence testing, stability testing) and requirements identified by individual states.