Thaisa Dezani

About Thaisa Dezani

Dedicated and dynamic professional with over six years of experience in pharmaceutical industry. Confident in my ability to foster collaboration across departments and with external partners to ensure optimal alignment with regulatory compliance standards. Recognized as a key contributor to EMS Pharma’s successful first-to-file submission of a GLP-1 analogue, along with other impactful filings with the FDA, EMA and ANVISA. Proud to have been part of the development process that led to the approval of a GLP-1 analogue by ANVISA in December 2024 - a pivotal milestone unlocking opportunities for competitive treatments in diabetes and obesity. Demonstrated leadership in coordinating the Regulatory Department, overseeing high-impact projects that drive organizational success. Committed to continuous professional development and dedicated to fostering team growth and success through proactive and strategic approaches. As a professional, I bring an optimistic and collaborative approach, thriving on interactions to achieve success through teamwork. Skills and experience: regulatory affairs, regulatory compliance, generics, resilience, teamwork, combination product, small molecules, peptides, GLP-1, eCTD, FDA, EMA, ANVISA, INFARMED, NDA, ANDA, IND, CTA, MAA, document management, quality assurance, risk assessment, cross-functional collaboration, audit preparation, gap analysis, attention to details, critical thinking, emotional intelligence, GxP.

Experience

1. Document Control Specialist

   Instituto Vita Nova

   Mar 2024 — Present

   Documentation Management• Assisting Managers/Coordinators and project teams in document management, track regulatory documents for initial submissions, deficiency letters, post-approval, and annual report. • Quality documents for NDA, IND, ANDA, MAA: medical writing, authoring support, and reviewing reports/documents related to drug development, DMPK and BA reports, process validation, method validation, drug substance / product specifications, manufacturing, stability data, clinical study reports, and risk management plans for regulatory submissions to US FDA, EMA and ANVISA in CTD format.

Education

• USP - Universidade de São Paulo

  Doctor of Philosophy (PhD)

  2013 — 2017

• USP - Universidade de São Paulo

  Master of Science (MSc)

  2009 — 2012

• Universidade São Judas Tadeu

  Bachelor's degree

  2005 — 2009