
Regulatory Affairs Specialist - LATAM
1w1 week agoIFF
AR · Full-time · ARS 2,500,000 – ARS 4,500,000
About this role
Execute complex and strategic product registration activities required for processes dealing with the Ministry of Health. Ensure the provision of application files and prepare marketing authorization applications. Responsible for the management and obtainment of regulatory approvals and registrations for all products and flavorings manufactured at the Argentina site, before INAL and SENASA.
Perform follow-up on potential changes in previously registered products and renewal deadlines. Provide additional documentation for registration revisions and renewals throughout the evaluation process. Ensure efficient and effective archiving of all documentation.
Direct interaction with regulatory authorities, coordination with external consultants and trade associations. Close collaboration with internal stakeholders including Regulatory, Quality, R&D, Commercial, and Supply Chain. Communicates effectively between departments and external associations with varying priorities.
May coach less experienced registration specialists and provides guidance as subject matter expert. Demonstrating continuous learning mindset and flexibility to expand expertise into new regulations. Participate in trade associations in a lead role specific to expertise.
Requirements
- Regulatory expertise and experience working with Argentine regulatory authorities including INAL and SENASA
- Ability to manage multiple stakeholders with varying priorities
- Product knowledge for flavors, colors, food ingredients, and product safety in LATAM
- Detailed understanding of regulations, product claims, and certifications applicable to customer requirements
- Advanced system and regulatory expertise to meet customer requests and regulatory changes
- Networking and advocacy with International, Regional, and Local Trade Associations for LATAM Argentina
- Articulate and execute GRA Strategy for compliance
Responsibilities
- Execute complex and strategic product registration activities for Ministry of Health processes
- Prepare marketing authorization applications and provide documentation for revisions and renewals
- Manage regulatory approvals and registrations for products and flavorings at Argentina site before INAL and SENASA
- Direct interaction with regulatory authorities, external consultants, and trade associations
- Collaborate with internal stakeholders (Regulatory, Quality, R&D, Commercial, Supply Chain)
- Provide customer and internal technical information requests for LATAM region
- Document and improve processes; follow trends in customer information demands
- Perform follow-up on product changes and renewal deadlines; ensure archiving of documentation
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