• Practical experience in pharmaceutical regulation: small molecules, biological products in compliance with Latam requirements, ICH guidelines and scientific and company policies and procedures.• Communicate regulatory expectations, develop regulatory strategies (CMC) and risk assessments for new drug application (small molecues, biological) and maintenance of the life cycle in compliance with applicable regulations.• Guidance of other CMC Regulatory Affairs professionals in the preparation of specific documents for each country in compliance with current legislation.• CTD Writer: Preparation and review of CTD module 3 and module 2 (QOS) files.• Work in cooperation with regional and global regulatory sites to support the accurate and timely communication of critical information.• Communication with Regulatory Athorities: meetings, response to official letters, response to questions (query).• Project Managment for regulatory submission

Direct performance in analytical documentation for regulatory actions (post registration, registration, renewal)Approval and review of validations of analytical methodologies.Adequacy of international validation guides to RE899/03.Evaluation of pharmaceutical equivalence studies, dissolution profile, and dissolution method developmentAdequacy of forced degradation studies to RDC58/13.Presence in the company's international validation committee, acting in public consultations of the main regulatory bodies such as FDA, USP, ANVISA, ICH.API and finished product stability study: Adequacy to RDC 318/2019

Development and analytical validation of cleaning methodologyStatistical evaluation of validation parameters through VoAM softwareQuality control analysis of equipment cleaning residuesWorst case choice, product bundling, analytics provider auditDomain of UPLC and HPLC technique (Waters – software alliance), CG (Agilent).Management of corrective/preventive actions and action plan.Elaboration of operational and technical procedures and general methods of analysis

Pharmaceutical equivalence analyzes and dissolution profileElaboration of method validation protocols and reportsstability studyMethodology developmentDevelopment of dissolution method