Daniela Peraza

WORK HISTORY

EDUCATION

ABOUT DANIELA PERAZA

Regulatory Affairs professional with over 15 years of experience in regulatory matters, technical writing of CMC sections for NDA submissions, Regulatory meeting requests, Regulatory meeting packages, and other communications with regulatory authorities. Experienced in formulating responses to Information Requests, responding to FDA inspection Form FDA 483 findings, protocol and report authoring, and related activities.CORE QUALIFICATIONS• Knowledge of US and international regulatory requirements and standards associated with the registration of drug products, cosmetics, and dietary supplements.• Trained Pharmacist with expert comprehension of pharmaceutical and medical terminology.• Skilled in fostering communication and building relationships with coworkers, customers, and regulatory authorities.• Good knowledge of the QMS process, GMP documentation practices, and product labeling requirements.• Experienced in authoring CMS sections for NDA and/or NDA supplement submissions• Experienced in applying for and processing Export Certificates, Certificates of Free Sales, and Certificates of Pharmaceutical Products.• Fluent in Spanish