João Caetano Email & Phone Number

State Of São Paulo, Brazil

Greater São Paulo Area

Serving as the primary scientific expert for Sanofi products, I directly managed both staff and budgets, guiding teams to excel in dynamic environments. I liaised with the Marketing Team, trained the Sales force, and participated in defining field activity plans. Leading and participating in teams for the creation and review of Scientific Promotional materials, I received the Sanofi Global Recognition Award in 2023 for leadership in the HCP Science Visualization Edutainment initiative. In the realm of Scientific Engagement, I organized Symposia in Congresses, Forums, Advisory Boards, and Events for HCPs. This included liaising, selecting, and contracting Key Opinion Leaders (KOLs).I served as the Project Manager and Scientific support for Real World Evidence (RWE/RWD) and Bioequivalence Clinical Studies, adhering to ANVISA, FDA, EMA, and ICH guidelines. I oversaw the generation of evidence for safety and efficacy data to support new claims, indications, labeling changes, and product launches. This facilitated the flawless/timely submission of dossiers for significant innovation launches in 2023, 2024, and 2025. Directly supervising monitoring personnel, I routinely assessed metrics, conducted joint monitoring visits. Also, I have worked with Regulatory Affairs (RA) and Legal for CROs contracting and served as the primary contact for them. I identified new sites and investigators, led initiatives across departments to assess study feasibility, generate insights, and proposed solutions. I led teams for preparation and review of Study Design and protocol, IRB submission and related start up documentation as well as preparation documents for product registration. Collaborated with Pharmacovigilance and RA for the review of PBRERs, PSURs, timely responses to Health Authorities, and support for legal litigations.

São Paulo Area, Brazil

Development and Implementation of Medical Strategy – aligning Global and Local teams.MA Representative for global projects, launches & life cycle management of Medicines, OTCs, and Devices. Key areas : Antihistamines, Antivirus, Antifungals, Antibiotics, Corticosteroids, Wound healing and recovery, Retinoids, NSAIDs, and othersServed as Team lead for the creation of product briefing documents for Internal Safety Board review and approvals.Medical lead supporting the preparation and review of documentation for clinical trials, clinical overviews for regulatory submissions .Medical Affairs representative in interactions with Health Authorities, PSURs, Assessments, Health Authority information requests.Responsible for leading important Rx to Cx Switch initiatives. Awarded with Silver Employee Recognition 2020 - Switch projects for Russian and EU markets.Scientific partner for cross-functional teams in the product lifecycle management, from product innovation through to patient/consumer launch.Organized and participated in advisory boards with KOLs. Chairperson in multidisciplinary boards for the creation, review and approval of new and improved expert communications. Using KOL insights, redesigned new materials in short period of time, resulting in relevant share increase in major markets.Evidence generation with Clinical/Real World Evidence (RWE) studies to support Expert/Consumer communications.Successfully supported multiple product launches.Led the creation state-of-the-art contents for media, digital training and visitation of HCPs, collaborating for results 15% above plan.Champion for the improvement of internal processes and evaluation of relevant Medical Affairs KPIs.Lead presenter for internal and external training in conventions, meetings and congresses. Published clinical studies and review manuscripts in international peer reviewed journals and congresses

Research Triangle Park, Nc, Usa

• Served as regulatory lead for regional and global teams, providing constant and relevant Regulatory updates on strategy, risks, change policies, mitigation strategies and any new local RA developments.• Managed RA Operations staff responsible for coordinating and maintaining master global product dossiers. Led the development of Master dossier process according to local and regional inputs, which was recognized with Global Employee Recognition Award 2010. • Directly worked with CMC writers and functional experts clarifying new or existing local requirements for the preparation of CMC modules and updates, which effectively facilitated timely responses to regulatory agencies resulting in faster approvals.• Led and coordinated development of Regulatory strategy and lifecycle management plans, aligned to internal global strategy and local requirements always collaborating closely with scientific, technical, quality and supply chain members.• Ensured timely responses and follow up in interactions with Health Authorities (FDA, EMEA, MHRA, ANVISA, others). Provided regulatory assessments of manufacturing changes within the change control system and filing strategy guidance to Technical Operations and Quality department. • Focal point for regulatory guidance to other functions, maintaining communication and awareness of new/updates on local regulations and CMC requirements. • Review of campaigns, promotional materials and labeling, ensuring regulatory compliance.• Participated in industry networking activities to maintain current knowledge on best practices ensuring excellent internal cross-regional and cross-functional communication on new developments.

Research Triangle Park, Nc Usa

• Served as CMC lead - broad technical and strategic leadership for the Chemistry, Manufacturing and Controls area, leading the design of new formulations and processes. A total of 30+ SKUs were successfully launched in Europe, Americas and Asia including medicines, OTCs and cosmetics. • Supported the preparation of CMC sections for regulatory filings, working closely with CMC writers providing required source documentation on time to enable product launches, market expansions, post-marketing and regulatory commitments.• Responsible for sub team project management (formulation, process development, chemistry, microbiology, physical testing, stability quality and others), reporting technical and timeline information to PMO, core team, stakeholders and functional heads. • Managed overall governance process to document, assess, prioritize, and deliver product enhancements and roadmap initiatives, tracking risks and issues, including escalations to management• Authored and/or reviewed technical CMC documentation, including technical reports, batch records, protocols and change controls. Identified and implemented opportunities for process continuous improvement in multiple products and formulations.Collaborated with the Clinical/Medical team to determine the best strategies to substantiate claims,successfully prove formulation performance and safety for several products.

Weybridge, South London - Uk

Formulation and Process Development of new technologies for Innovation Projects. Product Performance testing. Development of In vitro tests for claim substantiation work. Participation on the development of technical material for Marketing and sales representatives.

Participation in Regional and Local Project teams. Responsible for Formulation and Process development for key company franchises .Main activities: Innovation, Cost Reduction, Production Support and Troubleshooting.

Ribeirão Preto Area, Brazil

Development of multiple and simple emulsions with liquid crystals, testing of new natural sustainable raw materials, new suncare technologies. Published a total of 8 posters and scientific articles in congresses.

Master In Pharmaceutical Sciences, Pharmacy, Pharmaceutical Sciences, And Administration, Gpa 3.90

Master Of Business Administration - Mba, Business Management, 9,5

Pharmacy And Biochemistry, Ciências Farmacêuticas

Specialization in Industrial Pharmacy (2002 –2003) Universidade de São Paulo ( USP – Sao Paulo - BRAZIL) Pharmacy and Biochemistry (1999.