• Monitor, interpret, and analyze national and international laws, regulations, and regulatory guidance, evaluating their impacts on the business. • Ensure regulatory compliance of Active Pharmaceutical Ingredients (APIs), biological products, medicines, ingredients, food additives, and foods, as applicable to the company’s portfolio. • Prepare, review, and maintain regulatory dossiers for ANVISA and other national and international regulatory authorities. • Prepare and update technical documentation in CTD format, including Drug Master File (DMF) and other regulatory documents. • Participate in technical discussions for regulatory feasibility assessments of new projects, new products, and process changes. • Manage post-approval regulatory processes, including variations, additions, adaptations, and renewals, ensuring compliance with legal requirements. • Develop regulatory intelligence analyses, identifying trends, opportunities, and risks to support company strategy. • Identify and mitigate regulatory risks, proposing technical and regulatory solutions to ensure business continuity. • Coordinate the collection of information from technical areas for the preparation of protocols, reports, and regulatory documentation. • Oversee the renewal of licenses, permits, operating authorizations, certificates, and other mandatory documents with regulatory authorities. • Provide technical support during internal audits, health authority inspections, and client audits. • Act as the interface between internal departments and regulatory authorities, promoting technical and regulatory alignment.

• The Senior Quality Control (QC) Analyst is an advanced level position and hands-on role within the CTMS team that will support the lifecycle management of CTMS Data Quality Control. • Executing the Velos eResearch QC plan across the PSJH enterprise. • Assisting in creating SOPs and QC reports. • QC execution and study team training. • Identifying key operational process improvements through the data and trends that are brought to light via the QC process.

• Conduzir análises cadastrais de Pessoa Jurídica, incluindo casos de maior complexidade; • Analisar atos constitutivos, estruturas societárias, naturezas jurídicas e poderes de representação; • Identificar beneficiários finais e validar cadeias societárias; • Aplicar e interpretar regulamentações relacionadas a Cadastro, KYC e PLD/FTP; • Mapear riscos, gargalos e oportunidades de melhoria nos processos cadastrais; • Traduzir requisitos regulatórios e regras cadastrais em regras de negócio; • Apoiar iniciativas de automação, inteligência artificial e ganho de eficiência operacional; • Analisar indicadores e dados para apoiar a tomada de decisão; • Atuar de forma colaborativa com áreas como Compliance, Jurídico, Produtos e Tecnologia.

• Work with other Quality Engineers to ensure the quality of releases; • Automating and maintaining tests in a web context; • Execute manual and automated regression tests; • Bug management; • Maintain a positive attitude in problem-solving and suggest continuous improvements; • Actively participate in the Quality community by sharing knowledge;