• Create and follow up on insight applications, events, and tasks 

• Clarify regulatory questions from Business Units (BU) 

• Complete local registration applications and design monographs for Brazilian submissions 

• Draft technical reports and monographs that support registration history 

• Manage and distribute legal documents (CFGs, FSCs, ISOs) 

• Oversee translation management for assigned clusters 

• Build and validate dossiers for all LATAM countries, including double-checks for Mexican submissions 

• Coordinate submission planning with Business Partners and Operating Units 

• Respond to government inquiries and support RAN management under RA Manager guidance 

• Notify stakeholders of approvals across sOU, international, regional, and local teams 

• Verify and validate data for publication in regulatory databases 

• Collaborate with Sr. RAS, Associate RAS, and Project Coordinators 

• Train regulatory teams on LATAM regulations and workflows 

• Attend internal and external regulatory training sessions 

• Provide data for statistical reports and support budget tasks for LATAM countries 

• Assist Regulatory Operations with RAC assessments, blocked orders, and batch releases 

• Support audits, importations, tenders, and inventory deployment as needed 

• Stay current on regulatory legislation and guidelines 

• Maximize team efficiency by executing strategies that impact the broader RA function (e.g., master dossiers) 

• Maintain tracking tools (Excel, Smartsheet) for regulatory process advancement 

• Provide backup support to fellow RAS team members 

• Actively participate in strategic reviews and SSC projects with international teams 

Required Knowledge and Experience: 

• Bachelor’s degree in Pharmaceutical Sciences, Industrial Engineering, Biomedical Engineering, or related field 

• Minimum 2 years of experience in regulatory affairs 

• Advanced proficiency in Spanish and English (reading, writing, speaking) 

• Fluent in English; Portuguese proficiency preferred 

• Experience in medical devices or pharmaceutical industry 

• Strong understanding of LATAM regulatory environments and market dynamics 

• Ability to work in a matrix-structured organization 

• High proficiency in Microsoft Office tools and database management 

• Excellent communication and presentation skills 

• Strong analytical, problem-solving, and decision-making abilities 

• Ability to manage multiple projects and meet deadlines 

• Team-oriented with a proactive and strategic mindset