Kelly R Seraphim Coelho Email & Phone Number

São Paulo, Sp, Brazil

Campinas, Sp, Brazil

Responsible for developing the regulatory strategy and ensuring that it is implemented in relation to projects of registration, post-registration, renewals of products (OTC and Rx) and active pharmaceutical ingredients, including DMF (Drug Master File) evaluation, regulatory processes of the company (GMP, Licenses and other Certificates), promotional campaigns, elaboration and management of budget for the area, among other activities.• Interacting with Regulatory Authorities (ANVISA, VISA, Pharmaceutical Council...) to clarify/present/prioritize of products and projects.• Support to the Board in innovations and strategic projects, related to regulatory environment (Acceleration of New Registers, Startup, Lifecycle Management with focus on saving and absence of disruption, accompanying sanitary inspections at factories.• Representing the company before Health Authorities (ANVISA, VISA, Pharmacy Council etc.) and Associations (Sindusfarma, Pró-Genérico and ABIMIP).• Restructuring of Regulatory Area focusing on deliveries/company’s strategies, being the department with low staff turnover for 7 years, high level of productivity and computerized processes, including databases.• Proactive commitment in setting up technical guidelines with Associations (Sindusfarma, Pró-Genérico, ABIMIP) and ANVISA, managing internal contributions to these proposals.• Interface with other areas in the Group, including Global and Regional teams, in order to define business strategies and risk mapping;• Regulatory management of merger, demerger and incorporation of company processes (SANOFI, Medley).

Campinas, Sp, Brazil

• Group coordination, including work demands.• Elaboration and monitoring processes:- Registration, Post-Registration and Renewal of New drugs, Biological, Branded Generics, Generics products and herbal medicines;- Registration of active pharmaceutical ingredients;- Meeting compliance requirements;- Health documents including GMP (Good Manufacturing Practices) certification and Exportation licenses.• Support to other areas in the company related to regulatory impact assessment of business strategy, as well as monitoring of internal implementation of ANVISA’s new requirement. • Participation in internal projects to design and definition of working flows, procedures, KPI, databases, etc.• Risk assessment related to the submission of new products and post-registration.• Negotiating deadlines and documents with manufacturing sites or affiliates in attendance with regulatory requirements.• Participation in Association meetings as well as meetings at ANVISA.

Campinas, Sp, Brazil

• Preparation of registration and post-registration of synthetic drugs (Branded Generics, Generics, New Products) dossiers.• Registration of active pharmaceutical ingredient. • Provide support for other areas of the companies related to regulatory impact.• Preparation of processes related to submission and renewal of the health documents/certificates including GMP- Good Manufacturing Practices and licenses/activities referring to Brazilian Ordinance 344/98 (controlled substances and products).• Participation in meetings at Associations.

Hortolândia, Sp, Brazil

• Preparation of registration, renewal and post-registration of similar and generic drugs dossiers • Preparation of processes related to submission and renewal of the health documents/certificates including GMP- Good Manufacturing Practices and licenses/activities referring to Brazilian Ordinance 344/98 (controlled substances and products).

Desenvolvimento De Executivos

Desenvolvimento Contínuo

Gestão Empresarial

Farmácia-Bioequímica

Activities and Societies: Programa de Iniciação Científica na Área de Toxicologia