Seasoned individual contributor who works independently with minimal supervision to coordinate regulatory activities for assigned projects across Latin America (LATAM). Leads regional planning and execution by tracking regulatory requirements and submission status, defining regional strategies, and aligning country teams to deliver project milestones on time and in compliance with corporate policies and applicable regulations. Establishes and maintains a regional regulatory execution plan for projects in scope, including country‑by‑country submission/registration pathways, key assumptions, dependencies, risks, and mitigation actions. Coordinates cross‑functional and country Regulatory Affairs stakeholders to ensure alignment on regional strategy, deliverables, and timelines, supporting timely market access across all countries in scope. This role has no direct reports and drives outcomes through cross‑functional leadership, influence, and effective stakeholder management. Essential duties and responsibilities Coordinate and drive day‑to‑day regional regulatory activities for assigned projects across LATAM, ensuring consistent execution across all countries in scope. Develop and maintain the LATAM regulatory strategy and execution plan (submission/registration pathways, sequencing, assumptions, dependencies, and resource needs) in partnership with country Regulatory Affairs teams and global/regional stakeholders. Build, manage, and communicate an integrated, country‑by‑country project timeline; track milestones, critical path, and deliverables; and proactively escalate risks, issues, and decision points. Track regulatory changes and intelligence relevant to the project; assess impact to scope, documentation, and timelines; and recommend mitigation actions to maintain compliance and business continuity. Coordinate inputs and reviews for submission dossiers/technical documentation (as applicable), ensuring alignment of content, quality, and readiness for country submission. Facilitate governance routines (regional core team meetings, action logs, decision logs) and provide clear status reporting to stakeholders, including dashboards/metrics on progress and performance. Partner with RA Clusters, Quality, R&D, Supply Chain, Marketing, and other functions to ensure alignment to regional launch plans and on‑time readiness activities. Support country teams in planning interactions with Health Authorities (e.g., meeting strategy, questions/responses coordination) and consolidate regional inputs to ensure consistency. Apply Company’s Credo and Leadership Imperatives in day‑to‑day interactions with internal and external stakeholders. Provide guidance and knowledge sharing to colleagues on regional regulatory coordination processes, tools, and best practices, as needed. Special requirements Proficient in English and Spanish languages. Bachelor’s degree in pharmacy, chemistry, biochemistry, or a related field. Comprehensive understanding of medical device regulations specific to Latin American countries (e.g., ANVISA in Brazil, COFEPRIS in Mexico). Experience coordinating multi‑country regulatory submissions/registrations and managing project plans/timelines across LATAM is preferred. Essential knowledge and skills Comprehensive knowledge of medical device regulations and submission processes specific to Latin America countries. Skills in assessing the impact of local regulations on product development and marketing strategies. Strong organizational and project management skills to handle multiple regulatory submissions and timelines across jurisdictions. Core competencies required for this role Leadership (influence without authority) Strategic Thinking Effective Communication Decision‑Making and Problem‑Solving Abilities Capacity to work effectively with cross‑functional teams (R&D, quality assurance, marketing) to ensure regulatory compliance throughout the product lifecycle. #J-18808-Ljbffr