Compliance

• Lead and support submissions in Latin American markets for MAAs and life-cycle management procedures
• Provide local expertise as a member of the Global Regulatory Affairs team
• Drive and coordinate regulatory strategy and local regulatory activities in Latin America
• Provide regional regulatory expertise for geographical expansion
• Track Health Authorities’ requests and relevant new local regulations
• Maintain current knowledge of local requirements and communicate regulatory changes to senior management
• Lead cross-functional Vertex teams through submission planning, preparation, submission, and review
• Prepare responses to regulatory questions
• Prepare timelines and create submission binders in Veeva
• Keep submission and correspondence files up to date
• Act as local expert for regulatory queries from medical, supply chain, and other functions
• Ensure work complies with regulatory requirements and company policies and procedures

Compliance jobs in Chile

Regulatory Strategist – International, Manager