Priscilla Siqueira Kuczynski

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1.A. Regulatory Affairs Manager ? Post-Approval Changes and BE. Since Jun 2017.  PMO for post-approval changes mainly impacting supply to Brazil market  Implementation of governance with critical interfaces: SCM, QA, CMC, PSM, RA  Definition of regulatory strategy for post-approval filings  Focal point for post-approval changes with Health Authority and within RA  Head of conditional approval project involving a cross-functional team, very tight timelines and risk assessments. Savings: US$ 21M  Set up of audit-readiness for ANVISA in loco visits  Focal point for bioequivalence issues and strategy  People management: one direct report 1.B. Regulatory Affairs Coordinator ? Products Registration. Nov 2005 to May 2017.  Responsible for Primary Care products (respiratory, diabetes, cardiovascular)  Strong and intense interaction with Global and Regional Regulatory Affairs: regulatory requirements and assessments, implementation of new regulations, regulation trends, definition of strategy for new projects, monitoring  Focal point of labeling at Regulatory Affairs Brazil  Support to Regulatory and Competitive Intelligence activities  Knowledge of and experience in applying six sigma and lean methodologies: implementation of metrics vision in the regulatory area (KPIs), change management skills with a continuous improvement focus, support to regulatory excellence (SOPs, CAPAs, audits)  People management: organization with 1 analyst and 1 trainee  Main challenges: - Implementation at country level of the new Global Submission Operating Model - Regional pilot project of a dashboard to control safety label updates submissions - Coordination of Bioequivalence studies for filing of new FDCs. - First electronic submission of a NDA in MSD Brazil. - Coordination of labeling development of all legacy Merck products for the implementa

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Coordenadora de dados de pesquisa clínica de estudos realizados pela MSD.  Main achievement: Continuous Data Flow implementation at the subsidiary.

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Monitora de pesquisa clínica em estudos de oncologia e infectologia.

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Monitora de pesquisa clínica em estudos fase IV