Regulatory Affairs Professional
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Extensive experience managing regulatory affairs from the perspectives of Health Authorities, local distributors, and international pharmaceutical companies.
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Proven Regulatory Experience in the Caribbean, LATAM and Europe.
Skilled in managing Pharmaceutical Product Information including PILs, SmPCs, Labeling and Marketing Material in Dutch, English, Papiamentu and Spanish.
Provides Medical Document Translation Services in Dutch, English, Papiamentu and Spanish
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My. Services.
Regulatory Affairs & Pharmaceutical Product Specialist
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Management of Marketing Authorization Applications (MAAs) from submission to approval.
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Pharmaceutical Product Life Cycle management including Renewals, Modifications, Notifications and Withdrawals.
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Conducting Regulatory Intelligence Surveys for Caribbean and Latin American Countries.
Health Information & Product Information Management
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Management of Labeling texts for primary, secondary packaging, and patient information leaflets.
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Design and Revision of Educational and Marketing Material for Pharmaceutical and other Health related products
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Medical document translation services in Dutch, English, Papiamentu, and Spanish.