Sheila Mary Inada

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Responsible for developing regulatory strategies for all products. Leading all activities related to obtain and keep all registrations and certifications of the company, aligned with business necessities and according to local regulations and Corporate procedures. Responsible for establishment and maintenance of efficient relationship with Health Authorities. People development according business expectation following Talent Management program. ? Ensure regulatory intelligence (information, news, changes on legislation and regulatory environment, movement of competitors) by analyzing the information/changes impact on the local and Internacional business, keeping the company duly informed and proposing plans for necessary regulatory compliance; ? Participate on local legislation reviewing, with strategic contributions to the business, through close participation with Associations; ? Building and maintaining close and trust relationship with the Brazilian Health Authorities (ANVISA, CVS); ? Assure registration approvals of all new products and line extensions in optimal approval's timelines in order to keep company's competitiveness into local pharmaceutical marketing; ? Assure the business and sale maintenance through updating and renewing of products registration, following legal deadlines and according to legislation; ? Obtain and keep the company's sanitary documents through management of related regulatory activities, including GMPs; ? Review process (focus on critical points) of major impact on business to be submitted in Anvisa; ? Continuous improvement actions to reduce the approval time - strategic management; ? Ensure that the package insert and labeling texts are periodically revised based on Corporate documentation to maintain regulatory compliance; ? Monitor quality and regulatory affairs team performance including productivity and periodic follow-ups; ? Managing the regulatory process of dossiers preparation in order to achieving business o

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Main accomplishments  Registration and post-registration changes for New products, Biological, Generic, Branded Generic.  Responsible for managing safety updates in the packaging inserts in order to guarantee the compliance with local regulation (RDC 47/09) and Global timelines as well.  Packaging material revision and promotional material.  Support to Marketing, Pharmacovigilance, Supply Chain, Quality and Medical teams.  Coordination of transversal project with packaging material and safety information updates as well legislation updates.  Regulatory intelligence initiatives.  Participation on meetings, working groups and workshops on ANVISA, including meeting with members of the Health Agency.  Regulatory evaluation of new product development

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Main accomplishments  Registration and post-registration changes for New products, Biological, Generic, Branded Generic.  Packaging material revision and promotional material.  Support to Marketing, Pharmacovigilance, Supply Chain, Quality and Medical teams.  Management of the new request and renewal of Sanitary Permit, Functioning Permit, Special Functioning Permit and Pharmaceutical Certification (Legal Documents).  Support to Regional Regulatory Affairs ? submission activities across LATAM.  Participation on meetings, working groups and workshops on ANVISA, including meeting with members of the Health Agency.  Creation, evaluation and monitoring of competitors

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Main accomplishments  Registration and Post-registration changes for OTC products, cosmetics and medical devices.  Monitoring of competitors activities to support.

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Padrão Uni e Bidimensional de protéinas imunodominantes do extrato de excreção/secreção de Neospora caninum (Bolsista FAPESP).

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Projeto de Iniciação Científica: Padrão uni e bidimensional de proteínas imunodominantes do extrato de excreção/secreção de Neospora caninum (Bolsista PIBIC)