Carlos Langezaal, PhD, Senior Director of Regulatory Affairs, is a regulatory professional with 30 years of experience in Regulatory Affairs. Most positions were as Global Regulatory Lead, responsible for developing strategies to achieve regulatory and business objectives globally.

Carlos has experience across all stages of global drug development from pre-IND/CTA through Phase 3/registrational phase, and life cycle management of marketed products, including indication extensions and other filings. Therapeutic areas include allergy, respiratory, dermatology, general medicine, CNS, and hematology/oncology.

Carlos has prepared and led critical communications/interactions to/with global health authorities, such as meetings with the U.S. Food and Drug Administration (FDA) at all stages of development, with the European Medicines Agency (EMA) and (Co-)Rapporteurs regarding requests for information (Oral Explanations, etc.), and with the Japanese Pharmaceuticals and Medical Devices Agency (PMDA). He has also led many types of regulatory filings including NDA/MAA, IND/CTAs, sNDA/sBLA, and line extensions for new indications or safety label updates.