Regulatory Affairs LATAM Coordinator (part-time)

Contract: 12 months 

We are seeking a seasoned Regulatory Affairs professional to coordinate and lead regulatory activities for assigned projects across Latin America (LATAM). Acting as an independent individual contributor, you will drive regional planning and execution, track regulatory requirements and submission status, define regional strategies, and align country teams to ensure projects are delivered on time and in compliance with corporate policies and applicable regulations. This position involves cross-functional leadership and effective stakeholder management without direct reports.

Essential Duties and Responsibilities:

• Coordinate and drive day-to-day regional regulatory activities for projects across LATAM, ensuring consistent execution in all countries within scope

• Develop and maintain regional regulatory strategy and execution plans, including submission/registration pathways, assumptions, dependencies, and resource needs, in partnership with country Regulatory Affairs teams and global/regional stakeholders

• Build, manage, and communicate integrated, country-by-country project timelines; track milestones, critical paths, and deliverables; proactively escalate risks, issues, and decisions

• Track regulatory changes and intelligence relevant to projects; assess impacts and recommend mitigation actions to maintain compliance and business continuity

• Coordinate inputs and reviews for submission dossiers/technical documentation, ensuring readiness for country submission

• Facilitate governance routines (regional core team meetings, action logs, decision logs) and provide clear progress and performance status reporting to stakeholders

• Partner with RA Clusters, Quality, R&D, Supply Chain, Marketing, and other functions to ensure alignment and on-time readiness for regional launches

• Support country teams in planning interactions with Health Authorities and consolidate regional input to ensure consistency

• Provide guidance and knowledge sharing on regional regulatory coordination processes, tools, and best practices

Job Requirements:

• Proficiency in English and Spanish

• Bachelor’s degree in Pharmacy, Chemistry, Biochemistry, or related field

• Comprehensive understanding of medical device regulations specific to Latin American countries (e.g., ANVISA, COFEPRIS)

• Experience coordinating multi-country regulatory submissions/registrations and managing project plans/timelines across LATAM preferred

• Strong organizational and project management skills to handle multiple submissions and timelines

• Ability to assess the impact of local regulations on product development and marketing strategies

Core Competencies:

• Leadership and 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