Associate legal director, NOLA & South Cone region | BioMarin

Carlos Calderón
Associate legal director, NOLA & South Cone region | BioMarin
What are the key projects you have been involved in over the past twelve months?
Over the past twelve months, my role has focused on continuing to strengthen the legal framework across Spanish-speaking Latin America, moreover since I took the South Cone region in November, while acting as a strategic business partner for commercial and corporate functions. In BioMarin, this involves operating in a highly regulated healthcare environment, where legal input must balance innovation, patient access and strict compliance requirements.
A key focus has been on enhancing cross-functional collaboration with commercial, medical and market access teams to ensure that legal considerations are embedded early in business decision-making. This proactive approach has allowed the legal function to move from a reactive role to a value-generating partner, enabling faster and more robust execution of strategic initiatives.
Another important component has been supporting the expansion and operationalisation of business activities in complex markets within the region. This involves navigating multi-jurisdictional regulatory frameworks and aligning internal stakeholders around compliant and commercially viable solutions. My contribution has centered on translating complex regulatory requirements into practical tools and frameworks that enable business growth while maintaining a strong compliance culture.
Can you describe an instance where your legal advice directly influenced business strategy or commercial objectives?
One of the most relevant aspects of my role is bridging the gap between legal requirements and commercial strategy. A clear example of this has been in situations where regulatory constraints could potentially limit or delay market access strategies.
In one particular case, the business was evaluating different approaches to expand operations in a jurisdiction with evolving healthcare regulations and pricing frameworks. Rather than focusing solely on legal risks, my approach was to work closely with cross-functional stakeholders to understand the broader business objectives and identify alternative pathways that could achieve similar outcomes within the regulatory framework, specifically alternatives to direct sales business models.
How has the role of general counsel evolved, and what are the most important attributes for the modern in-house lawyer?
The role of in-house counsel has evolved significantly from being primarily reactive and risk-focused to becoming a strategic advisor embedded within the business. Today, legal leaders are expected to contribute not only to compliance and risk management, but also to business growth, innovation and organisational culture.
In my experience, this evolution requires a combination of strong technical expertise and a deep understanding of the business environment. Lawyers must be capable of translating legal concepts into strategic insights and actionable recommendations that resonate with non-legal stakeholders.
Equally important is the ability to operate across multiple jurisdictions and cultural contexts, particularly in regions like Latin America, where regulatory and market conditions vary significantly. This requires adaptability, strong communication skills and a collaborative mindset.
Finally, modern in-house counsel must act as champions of integrity and inclusion. Promoting ethical conduct and fostering diverse and inclusive environments are not only organisational priorities, but also key drivers of long-term sustainability and innovation
Beyond your legal role, is there a cause or initiative you are especially passionate about?
In addition to sharing my passion for business law, I actively promote the fight against bullying and all forms of discrimination and stigma related to race, sexual orientation and HIV status. Within BioMarin, I lead the Latin American chapter for Pride’s ERG.
What key trends should in-house counsel be monitoring over the coming months?
In-house counsel should closely monitor the increasing complexity of regulatory frameworks, particularly in highly regulated sectors such as healthcare. In Latin America, this includes evolving data privacy regimes, price regulation, regulatory pathway and structural changes in healthcare systems and market access conditions.
Additionally, the growing interest in regulating emerging technologies such as artificial intelligence is particularly relevant. Governments in the region are already exploring frameworks aimed at ensuring ethical and responsible use of AI, which will inevitably impact business models and compliance structures.
Another important trend is the need for greater regional integration and standardisation. While digitalisation has improved connectivity, there are still significant fragmentation challenges across jurisdictions, which require legal teams to adopt more harmonised approaches to governance and compliance.
Associate legal director North LATAM | BioMarin
Associate legal director - North Latam | BioMarin
Senior legal counsel – Andes Region | Abbott Laboratories
Head of legal and compliance - Andean zone | Siemens Healthineers
Carlos Calderón started his career at Lizarazu, Sossa and Peña, a boutique consumer goods and antitrust law firm, and was subsequently seconded to AbbVie, where he began specialising in healthcare...