Marcelo Arcos Email & Phone Number

South America

Strategic Consulting for Growth & Excellence in Regulated IndustriesWe're at the forefront of catalyzing significant growth and operational excellence. Our consultancy excels in merging deep industry insights with innovative process improvements and strategic foresight, crafting bespoke solutions that propel organizations towards market leadership and enhanced efficiency.Key Offerings:Strategic Partnership: We engage deeply with your leadership, developing and executing strategies that resonate with your core objectives and drive sustainable growth.Hands-On Execution: Our commitment extends beyond planning; we lead the tangible implementation of strategies, ensuring that plans are actualized with precision and lead to measurable outcomes.Enhanced Decision-Making: Armed with exhaustive market research and proactive legislative monitoring, we empower your team with the critical insights necessary for nimble, informed decision-making in a dynamic regulatory landscape.Beyond Compliance: Our audit and compliance strategies are designed not just to meet standards but to uncover strategic opportunities for optimization, driving efficiency and competitive advantage.Customer Experience Integration: Central to our approach is the elevation of the customer journey through targeted change management and continuous improvement initiatives, directly translating to increased customer satisfaction and loyalty.Optimized Supply Chain: We redefine supply chain management by strategically balancing cost and customer satisfaction, ensuring your supply chain becomes a resilient, strategic asset in today's competitive market.By partnering with us, you're choosing a path that not only navigates the complexities of regulated markets but also redefines them, positioning your organization as an industry vanguard. Let's collaborate to transform your strategic vision into a living reality, setting new benchmarks for success in your sector.

I spearheaded a strategic turnaround initiative that revitalized homecare division, driving substantial improvements across the entire value chain—from procurement to sales. My leadership was instrumental in redefining operational processes, expanding market reach, and enhancing financial and quality outcomes.Strategic Achievements:Supply Chain and Process Optimization: Revamped supply chain processes ensuring seamless compliance across Warehouse, Maintenance Workshop, Distribution, and Quality Systems. Upgraded and integrated quality systems to elevate operational efficiency and service standards.Cross-Functional Leadership: Fostered a culture of collaboration, leading joint efforts with Sales, Marketing, Market Access, Public Health & Medical Affairs, and Regulatory Affairs, to ensure a unified approach towards strategic goals and market expansion.Sales and Operational Leadership: Transformed the sales department's day-to-day operations, aligning initiatives with the company’s strategic objectives. Enhanced trading performance by instilling a culture of excellence and adherence to high standards.Business Expansion and Customer Acquisition: Engineered a robust business expansion strategy that extended our geographic footprint and diversified our customer base, significantly increasing market penetration and revenue streams.Financial Performance and Compliance: Implemented stringent compliance and quality protocols, resulting in improved profit margins and operational excellence. Established a framework that fostered financial health and legislative compliance.Data-Driven Decision Making: Developed and introduced a comprehensive dashboard, providing top managers and owners with vital data and analytics.Under my leadership, Avedis experienced a remarkable transformation, marked by enhanced operational processes, expanded market presence, and improved financial health. By instilling a data-driven culture and fostering cross-functional collaboration.

As a Change Management Consultant, I spearheaded a transformative initiative aimed at enhancing operational processes across the manufacturing plant. My role was pivotal in driving process improvements, ensuring stringent regulatory compliance, and elevating overall performance standards within a dynamic and highly regulated environment.Key Contributions:Process Optimization & Compliance: Led a comprehensive review and revamp of manufacturing processes to align with evolving regulatory standards, significantly improving efficiency and compliance across regulatory affairs, quality assurance, and quality control functions.Leadership & Mentorship: Cultivated a culture of positive leadership and continuous improvement, serving as a mentor to managers and a motivational leader to the broader team. My approach fostered an environment where innovation thrived, and challenges were viewed as opportunities for growth.Cross-Functional Collaboration: Worked closely with multiple departments, including Production, Medical Devices, and Warehouse, to ensure seamless integration of process improvements and regulatory practices. This collaborative effort resulted in enhanced operational cohesion and streamlined workflows.Quality & Safety Enhancements: Implemented strategic quality control measures and safety protocols within the production and medical devices areas, elevating product quality and ensuring the highest safety standards.Strategic Advisory: Provided strategic guidance on best practices in change management, process optimization, and regulatory adherence, empowering the organization to stay ahead of industry trends and maintain a competitive edge.Through strategic leadership and a deep understanding of the unique challenges in healthcare manufacturing, I successfully led the organization through a period of significant change, resulting in improved processes, enhanced regulatory compliance, and a motivated, high-performing team.

Buenos Aires Province, Argentina

 Profit and Loss responsibility Lead collaborative efforts with Sales, Marketing, Market Access, Public Health & Medical Affairs, Regulatory Affairs and other shared functions  Sales and Marketing management for Care Concept division, (disease management Sleep/ wound and respiratory business). Provides leadership to the day-to-day operations of the sales department, while maintaining focus on the company’s strategic goals and standards for financial and trading performance, quality, culture and legislative adherence  Establish market sales and resource forecasts, and also initiate relevant market research projects to support the strategic brand planning process. Analyze sales statistics to determine business growth potential.  Develops, or participates with the Senior Staff, in the development of the Strategic Marketing Plan for Healthcare market.  Coordinates sales operations with all other departments/divisions/regions in the Company.

 Lead and managing the Quality and Regulatory Affairs function in Venezuela, Aruba, Curacao, Colombia, Ecuador, Perú, Chile, Argentina, Uruguay and Brazil.  Leading a team of 47 health professionals in the region, being member of the RMT (Regional Management Team) and the QRA GMT (Global Management team) I participated in 6 new regulations development, with personal involvement in Argentina and Brazil, and leading QRA team in Ecuador, Perú, Uruguay and Colombia.  Government affairs management Open Pharmacopoeia Medical Gas discussion in different countries, Sub-Commission Member in Argentina (BO 30.172) 2 committees got in Chile and Brazil Make market actors aware about company’s products in the region, involving health deputy commissions at congress in Argentina and Brazil, professional bodies, enterprise chambers entities and regulatory actors in all the countries train Regulatory Authorities in Argentina, (INAME and Medical Technology), Brazil (ANVISA auditors) about medical gases, processes, Quality Assurance and Validation Implement in the region a Pharmacovigilance program according to international standards Implement a risk assessment in healthcare processes in 100% of the plants Lead and control QMED implementation. Performance monitoring and measurement. Regional bench-marking. Regulatory Development. compliance. Authorities Speaking partner Regional  Surveillance System Implementation  Presentations of records / dossiers seeking successful approvals; Maintenance of licenses; Compliance with local regulations and international standards Answer HA requests and / or any information document from or to the health authority Interact with the local Health Authority with the objective of properly monitoring the current files until they are approved Supervise, interpret and validate current and changing regulatory legislation and share the potential impact of these activities on products.

I Built a Quality and Regulatory Affairs pharmaceutical department in a based engineering and industrial companyI built a Quality team (Pharmacists) to made the difference in the market, getting authorities recognition and corporate global organization supportI make markets actors aware about the need to have a pharmaceutical standard leading authorities and actors to a safe place for patientsI was part of main actors in the market developing regulations according to international stds. Surveillance System Implementation  Presentations of records / dossiers seeking successful approvals; Maintenance of licenses; Compliance with local regulations and international standards Answer HA requests and / or any information document from or to the health authority Interact with the local Health Authority with the objective of properly monitoring the current files until they are approved Supervise, interpret and validate current and changing regulatory legislation and share the potential impact of these activities on products.  Follow trends and changes in regulation

As a plant Manager I was in charge of Quality control/Quality Assurance and Pharmaceutical Operations.Speaking partner with authoritiesMaintenance of licenses;Compliance with local regulations Answer HA requests and / or any information document from or to the health authorityFollow trends and changes in regulation

Lead a new team in an special Packaging Area, Train team in GMP/GWP, Fulfill production program.

Pharmacist, University

Activities and Societies: Asociacion Quimica Argentina,

Course, Marketing And Sales

General Management, Executive Circle

Activities and Societies: Management areas and financeIt took 80 hrs of training in 2 full weeks.

Master, Business

Activities and Societies: Master in Business Administration - Manufacturing companies orientation - EOI (Escuela de Organización.

Technician, Chemistry, Technician