Ariana Sanches Fonseca
Regulatory Affairs Specialist @Piramal Pharma Solutions
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WORK HISTORY
Regulatory Affairs Specialist @Piramal Pharma Solutions
Riverview, MI, US
Preparation and review of documents such as CMC, IND, NDA, MAA, DMF, Annual Review, Amendments and Supplements in compliance with applicable regulations established by FDA, OSHA and EPA; Preparation and review of Validation Reports and Process Performance Qualifications; Review proposed product changes for impact on regulatory status of the products; Provide regulatory guidance and support for development and production activities; Development and preparation of regulatory reports for submission to the regulatory bodies; Interact with auditors, regulatory bodies, customers and investigators.
EDUCATION
Etec Lauro Gomes
Chemical Technician
Universidade São Judas Tadeu
Bachelor of Pharmacy - BPharm, Industrial Biochemistry Pharmacy
RAPS - Regulatory Affairs Professional Society
Certification , Regulatory Affairs Certificate: Pharmaceuticals
FGV - Fundação Getulio Vargas
Master of Business Administration, Executive MBA – Pharmaceutical Industry
SKILLS
ABOUT ARIANA SANCHES FONSECA
Experienced pharmacist with demonstrated expertise in regulatory affairs and quality…
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