• 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:

• Bachelors 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