Rodrigo Estacio
Head of International Regulatory Affairs - Partner Markets @Incyte
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WORK HISTORY
Head of International Regulatory Affairs - Partner Markets @Incyte
DE, US
Built and now lead Incyte’s Partner Markets Regulatory Affairs function, designing the organizational structure, processes, and systems that drive operational excellence across partner markets.Negotiated and implemented regulatory contractual frameworks in distribution agreements, ensuring compliance and alignment with legal, commercial, and clinical priorities.Oversaw due diligence, partner selection, onboarding, and joint governance, enabling seamless collaboration with global stakeholders.Directed submission planning and execution across 20+ countries for lifecycle management (LCM) and CMC applications, supporting commercialization of oncology, hematology, and immunology assets.Provided early regulatory guidance to shape formulation, clinical development, and global strategy for pipeline programs.Spearheaded the expansion of Incyte’s regulatory footprint into new therapeutic areas and geographies, accelerating access for patients in underserved markets.Championed cross-functional initiatives to streamline processes, improve systems, and enhance quality and compliance across the enterprise.Lead and mentor a diverse team of regulatory professionals, fostering leadership growth, resilience, and continuous improvement.
EDUCATION
FGV - Fundação Getulio Vargas
MBA, MBA - Enterpreneurial Management
Universidade São Judas Tadeu
Bachelor of Pharmacy (BPharm), Pharmacy - Biochemistry
CNSL
Technician in Clinical Pathology, Clinical Laboratory Science/Medical Technology/Technologist
ABOUT RODRIGO ESTACIO
I am a global regulatory affairs leader with 23+ years in top biopharma (Incyte, Takeda, Bristol Myers Squibb, Janssen), where I’ve driven strategies that brought innovative therapies in oncology, hematology, virology, cardiovascular, metabolics, rare diseases and immunology to patients worldwide. My work has spanned submissions in 40+ countries, regulatory partnerships, and health authority engagements that enabled accelerated approvals and sustainable market access.At Incyte, I built the International Regulatory Affairs organization from the ground up, creating structures, processes, and governance that now support global partnerships and operational excellence. Previously at Takeda, I led oncology submissions across growth and emerging markets, including first-in-class filings in China and Brazil, while guiding early pipeline strategy. Across roles, I’ve been recognized for navigating complex regulatory environments and aligning science, strategy, and business to deliver results.What drives me is impact — for patients and for people. I’m passionate about mentoring diverse teams, fostering leadership growth, and simplifying the path for innovation to reach those who need it most. Colleagues describe me as collaborative, pragmatic, and resilient — a leader who can balance urgency with long-term vision. I thrive where regulatory strategy meets global collaboration and welcome opportunities to advance access, partnerships, and innovation in healthcare.
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