Regulatory Affairs Specialist CartagoHibrído

Position SummaryThe Regulatory Affairs specialist role is responsible for the flawless execution of regulatory activities before health authorities, specifically focusing on legal entity changes for foreign manufacturers, licensors, and local entities across Central America and the Caribbean. As part of this role, you will coordinate with manufacturing sites and related areas regarding the technical documentation required for company name changes on active licenses in Peru and Ecuador.
Key ResponsibilitiesStrategic Coordination & ExecutionContribute to the definition and implementation of regulatory strategies in agreement with the local RA Manager and internal stakeholders regarding the submission of legal entity name changes for company licenses. Support the preparation and tracking of regulatory documents, dossiers, and change requests submitted as part of the company transition project, ensuring compliance with local regulations and internal policies / SOPs. Support the regulatory activities required for local entity name changes before health authorities in Central American and Caribbean countries. Cross-Functional Collaboration & Risk ManagementWork alongside other functions (e.g., Marketing, CSC, Planning) to minimize any potential impact due to regulatory reasons during project-related changes on sanitary licenses. Provide early and timely visibility of potential challenges, issues, or risks associated with regulatory activities. Prepare case analyses and align communications with the local RA Manager to engage stakeholders and work together on developing mitigation plans. Coordinate with the local RA team on upcoming or ongoing procedures for product licenses to seek efficiency in the change process whenever possible, such as grouping changes that affect the same sanitary license. Compliance, Artwork, & Systems SupportSupport the development of regulatory texts required for packaging and artwork modifications, as well as the actual artwork modifications according to internal policies, SOPs, and guidelines for this project. Ensure compliance within defined activity workflows in line with company standards, completing all necessary training required to operate processes and use systems. Maintain compliance with training plans according to internal policies. Maintain required databases for regulatory compliance, regional reports, heat maps, systems, and processes. Required Qualifications & ExperienceExperience: 3 to 5 years of experience in Regulatory Affairs handling pharmaceutical products, medical devices, and sanitary products (Cosmetics). Regional Expertise: Proven experience working with Central American and Caribbean markets. Desirable Experience: Experience in strategic support activities related to legal entity changes, mergers, or acquisitions. Language Skills: Advanced English proficiency.