Maria Cecilia Diaz
Manager Global Regulatory Affairs at hameln pharmaceuticals ltd- Claim this Profile
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Spanish Native or bilingual proficiency
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English Full professional proficiency
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Portuguese Native or bilingual proficiency
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German Limited working proficiency
Topline Score
Bio
A Cecilia vai estar, como certeza, entre aqueles profissionais que a gente guarda com carinho na lembrança, pois é uma profissional competente, rápida, que não te deixa esperando respostas. O trabalho com ela sempre fluiu muito bem. Informal no trato, prática na resolução dos problemas. Sempre parceira! Uma ótima pessoa para trabalhos em equipe. Só tenho a agradecer e elogiar! Só posso desejar a você, sucesso e felicidade!!! Até uma nova oportunidade de trabalharmos juntos!
A Cecilia vai estar, como certeza, entre aqueles profissionais que a gente guarda com carinho na lembrança, pois é uma profissional competente, rápida, que não te deixa esperando respostas. O trabalho com ela sempre fluiu muito bem. Informal no trato, prática na resolução dos problemas. Sempre parceira! Uma ótima pessoa para trabalhos em equipe. Só tenho a agradecer e elogiar! Só posso desejar a você, sucesso e felicidade!!! Até uma nova oportunidade de trabalharmos juntos!
A Cecilia vai estar, como certeza, entre aqueles profissionais que a gente guarda com carinho na lembrança, pois é uma profissional competente, rápida, que não te deixa esperando respostas. O trabalho com ela sempre fluiu muito bem. Informal no trato, prática na resolução dos problemas. Sempre parceira! Uma ótima pessoa para trabalhos em equipe. Só tenho a agradecer e elogiar! Só posso desejar a você, sucesso e felicidade!!! Até uma nova oportunidade de trabalharmos juntos!
A Cecilia vai estar, como certeza, entre aqueles profissionais que a gente guarda com carinho na lembrança, pois é uma profissional competente, rápida, que não te deixa esperando respostas. O trabalho com ela sempre fluiu muito bem. Informal no trato, prática na resolução dos problemas. Sempre parceira! Uma ótima pessoa para trabalhos em equipe. Só tenho a agradecer e elogiar! Só posso desejar a você, sucesso e felicidade!!! Até uma nova oportunidade de trabalharmos juntos!
Credentials
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Value Added Medicines/Scientific, Regulatory and IP Analysis training
Symmetric TrainingDec, 2020- Oct, 2024 -
Emotional Intelligence Conquer
Escola ConquerNov, 2020- Oct, 2024 -
Project Management for Generics
Symmetric TrainingNov, 2020- Oct, 2024 -
Strategic Thinking
LinkedInJul, 2020- Oct, 2024 -
Teamwork Foundations
LinkedInJul, 2020- Oct, 2024 -
Communicating In the Language of Leadership
LinkedInJan, 2020- Oct, 2024 -
European Regulatory Procedures - EMA & National Requirements
The Center for Professional Innovation & Education (CfPIE)Jan, 2020- Oct, 2024 -
Global Regulatory Strategy for Pharmaceuticals
Regulatory Affairs Professionals Society (RAPS)Jan, 2020- Oct, 2024 -
Introduction to leadership
FGVJan, 2020- Oct, 2024 -
Project Management for Regulatory Professionals
Regulatory Affairs Professionals Society (RAPS)Jan, 2020- Oct, 2024 -
Brazilian Regulatory Affairs Procedures
Fundação Instituto de Pesquisas Farmacêuticas - FIPFARMAJan, 2013- Oct, 2024 -
Excellence in Project Management
Coursera -
Fundamentals of Project Planning and Management
Coursera -
Initiating and planning of projects
Coursera -
Project Management: The Basics for Success
Coursera -
Project management for Regulatory Professionals
Regulatory Affairs Professionals Society (RAPS) -
Stability of medicines and chemical inputs
Sindusfarma - Industry Syndicate of Pharmaceutical Products in the State of São Paulo
Experience
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Manager Global Regulatory Affairs
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Mar 2020 - Present
Develop, lead and ensure long and short-term multi-country regulatory strategies for the global projects and products under accountability. Development and manage as life cycle management strategies for the assigned global project/products, alignment with launch schedule and business objectivesInteraction with cross functional teams across a variety of disciplines and develop strategies on complex issues utilizing technical regulatory skillsetsResponsible to answer any regulatory questions related to the assigned global project/products and support interaction with health authorities, ensuring compliance with local regulations and accomplishing timing needsCreation, review and approval of eCTD dossier; management of justification documents and product information for global projectsEnsure timely communications of relevant topics, process progress, status and milestones to the business and to the Regulatory affairs DirectorGlobal regulatory intelligence outline as part of the mid-term global regulatory strategy; interpretation of applicable regulations and guidelines; provisioning of global regulatory expertise; development of risk assessments and mitigation planMentoring and development of junior colleaguesStakeholder and partners management of various levelsContribution to local and global process improvements
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Sanofi
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France
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory affairs Professional
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May 2018 - Apr 2019
Development of regional regulatory strategy; provision of regulatory expertiseDefinition, coordination and contribution to preparation of dossiers for registration, variation and renewal for regional regulatory products/projects Communication and coordination response with health authorities; ensuring compliance with local regulations and accomplishing timing needsRisk assessment of dossiers before dispatch, including technical viability for regional products/projectsEnsuring timely execution of registration plan for development regional projectsFocal point for communication with stakeholdersRegulatory database and regulatory requirements upkeep
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Mundipharma
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Pharmaceutical Manufacturing
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700 & Above Employee
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Regulatory Affairs Professional
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Apr 2015 - Jun 2018
Regulatory affairs management for Latam region and support for all regulatory activities for regional products/projects under my responsibility
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Regulatory Affairs Professional (6 mo closed contract)
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Apr 2014 - Oct 2014
Management of regulatory activities within Sanofi-Genzyme merger transition project in Latam region
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Regulatory Affairs Specialist - Latin America (freelance consultant)
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Jun 2013 - Mar 2014
Regulatory affairs management for Latam region for projects under my responsibility
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Bayer HealthCare
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United States
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Regulatory Affairs analyst
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Jun 2011 - May 2013
Regulatory affairs management and support for all regulatory activities for products/projects under my responsibility
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Regulatory Affairs analyst
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Nov 2010 - May 2011
Regulatory affairs management and support for all regulatory activities for products/projects under my responsibility
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Pharmaceutical Sales Representative
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Nov 2008 - Sep 2010
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Education
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2006 - 2010
Universidad de Belgrano
Degree in Pharmacy, PharmD, Pharmaceutical Sciences
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