Throughout my career, my ability to connect technical details with broader business strategies has been crucial to my success. I pride myself on my commitment to maintaining high ethical and quality standards, ensuring that all operations under my supervision not only meet but exceed regulatory expectations.My ability to work across multiple fronts – from business development to regulatory oversight – has given me a broad and detailed view of the industry, enabling me to drive initiatives that benefit not only the company, but also our customers and partners. With a keen eye on the future of regulation and a proven track record of success, I am always prepared to take on new challenges and continue to make a meaningful contribution to the Regulatory Affairs field.Today I am a Regulatory Affairs expert with 18 years of experience in the pharmaceutical market and 13 years focused on the regulation of medical devices in Brazil and LATAM, encompassing materials and equipment across risk classes I, II, III, and IV. Additionally, possesses experience in the regulation of cosmetics, dietary supplements, and medicines.Specialist in ensuring regulatory compliance according to ANVISA, INMETRO and ANATEL standards, with a proven track record in dossier submission and regulatory process management. Strong communication skills with regulatory bodies and partners, ensuring compliance and process efficiency.With experience in GMP Quality Management installation according to international standards such as ISO 13485, RDC 665/22, and MDSAP. Throughout my career, I have dealt with various aspects of regulatory affairs, according to the regulations RDC 751:2022, Ordinance 384/2020, RDC 830:2023, among others.
Ars Regualtory Affairs
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Consultant In Regulatory Affairs And QualityArs Regualtory AffairsBrazil
Angélica Silva Education Details
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Ictq - Postgraduate Institute For PharmacistsManagement Specialization In Regulatory Affairs In The Pharmaceutical Industry -
Specialization In Biochemistry / Pharmacy With An Emphasis On Clinical Analysis -
Specialization For Hospital Pharmacists In Residency Models -
Degree In Industrial Pharmacy -
Mba - Total Quality Management -
Internal Auditor Iso 13485:2016 -
Abnt – Brazilian National Standards OrganizationAuditor Líder Em Sistema De Gestão Da Qualidade - Abnt Nbr Iso 9001:2015
Frequently Asked Questions about Angélica Silva
What company does Angélica Silva work for?
Angélica Silva works for Ars Regualtory Affairs
What is Angélica Silva's role at the current company?
Angélica Silva's current role is Consultant in Regulatory Affairs and Quality.
What schools did Angélica Silva attend?
Angélica Silva attended Puc-Rs, Ictq - Postgraduate Institute For Pharmacists, Universidade Federal Fluminense, Universidade Federal Fluminense, Universidade Federal Fluminense, Universidade Federal Fluminense, Sgs Academy, Abnt – Brazilian National Standards Organization.
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