More than 12 years experienced in international pharmaceutical companies. Graduated in pharmaceutical sciences, with specialization in biochemistry and MBA in Business Administration by FGV. Deep expertise in strategic management in Regulatory Affairs. Extensive experience in Pipeline Development and New Products Governance. Deep experience in regulatory requirements and processes in following companies: BMS, Janssen, Glenmark, Dr. Reddy's and Ranbaxy. Eligibility for EU citizenship. Areas of expertise: - Regulatory Affairs - Clinical Development - CMC - Analytical and formulation development - GMP & Good Bioequivalence Practices - Intellectual Property - Business Management - Global Brand/Franchise alliances

International Strategy Lead - Associate Director Regulatory Affairs @ From June 2015 to Present (7 months) Sr. Regulatory Affairs Manager @ Regulatory filing strategy expertise driving business performance in delivering pipeline effectively. Therapeutical areas: CV, CNS, Virology, Metabolics, Immunology, etc... Delivering Primary Care and Specialty Care Portifolio with Top 5 best approval timelines and best label among big pharma industry. Clinical Trial Applications & strategic plan for clinical development program. CMC & Clinical expertise. KPI's development and maintenance. Regulatory Intelligence development and maintenance. Full alignment with business priorities and needs. Early input for early development assets. Co-development and promotion partnership expertise. International experience in Global Regulatory Processes and Clinical Development (Tour of Duty in US). From June 2010 to June 2015 (5 years 1 month) Sr. Regulatory & IP Affairs Manager @ Contribution for New Franchise Deployment in Brazil ( CV and CNS) and expansion of Oncology Business. Biossimilar drug development. Registration of New Drugs, Biologics, Biosimilars, Generics and Branded Generics in Cardiology, CNS & Oncology. Intellectual Property activities such as patent search, freedom to operate issuance, patent filing and trade marks management. From November 2008 to June 2010 (1 year 8 months) Manager RA @ Full licensing process of subsidiary in the country. Integration of acquired facilities and business units. Establishment of 3 product franchises. International regulatory filings. Registration of New Products, Generics, Branded Generics, Herbal Products, Health Care Products & Cosmetics. Pre-audit and inspection accompaniment of GMP and GBP ANVISA inspections. Intellectual Property management. Pharmacovigilance & Customer Service management. From May 2005 to November 2008 (3 years 7 months) Analyst RA & Pharmacovigilance @ Registration of Generics & Branded Generics in all therapeutical areas. Pre-audit and inspection accompaniment of GMP and GBP ANVISA inspections. Pharmacovigilance & Customer Service management. Packaging Development and management. From July 2003 to May 2005 (1 year 11 months) Trainee RA & Drug Safety @ Pharmacovigilance routine activities. Reporting of SAEs for local & federal HA. Review and update of labels through CCDS updates. From July 2001 to June 2003 (2 years)

MBA, MBA - Management Focus @ Fundação Getulio Vargas From 2009 to 2010 Bacharel em Farmacia-Bioquímica, Pharmacy - Biochemistry @ Universidade São Judas Tadeu From 1999 to 2002 Rodrigo Estacio is skilled in: Regulatory Affairs, Pharmacovigilance, Quality Assurance, Intellectual Property, GMP, Clinical Trials, Pharmaceutical Industry, Regulatory Submissions, GCP, Sop, Generic Programming, Biotechnology, Formulation, Medical Devices, Cardiology