Peter Pedro Caetano

WORK HISTORY

EDUCATION

SKILLS

ABOUT PETER PEDRO CAETANO

As a Senior Director and Global Regulatory Lead for multiple indications of novel biologicals, I lead and coach teams to register new medicines worldwide by leveraging my 16 years of regulatory expertise in biotech and pharma. From first in human clinical trials to approval, I have a track record of successfully leading interactions with health authorities such as US FDA, EU EMA, Japan PMDA, China NMPA CDE, or Brazil\'s ANVISA. This happens in therapeutic areas as diverse as neurology, rare diseases, endocrinology, oncology, rheumatology, or reproductive health. The teams I had the privilege to serve have done it all regulatory wise: CTAs/INDs, PIP/PSP, parallel advice, BLAs/MAAs; variations, advisory committees, commercial regulatory compliance, inspections, etc. I stay up to date with the latest regulatory developments, as well as those of overall biopharma, building on my eclectic past in biopharma which includes positions from manufacturing to pharmaceutical sales. This enables me to be a trusted adviser in selecting and developing drug candidates through internal and external innovation in many different conditions, including those with complex regulatory pathways or yet without regulatory precedent. I am passionate about bringing novel biological medicines to patients in need, and I am motivated by the thrill of working in a collaborative multi-functional environment. I am also a professor and researcher of clinical research and regulatory affairs, enjoying sharing my knowledge and learning from my students and colleagues. Finally, I have a solid academic background, which includes a PhD in Pharmaceutics, where at the University of Michigan I collaborated with FDA, USP (United States Pharmacopeia) and Viatris (formerly Mylan, UpJohn), with internships at BMS and Merck. Moreover, I completed an MPH at Harvard, PgDip at Oxford, PharmD at Ohio State, and MBA at ESSEC-Mannheim. These degrees where obtained while simultaneously working full time at Procter & Gamble (Health Care and Pharmaceuticals division), Genzyme-Sanofi, Allergan-Abbvie, and Ipsen.