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Paulo Agra
Regulatory Affairs Director na ABBOTT
Paulo Agra is a seasoned professional with 22 years of expertise in Regulatory Affairs within the Pharmaceutical industry and at the National Health Surveillance Agency (Anvisa).
His focus lies in Regulatory Management, particularly in R&D for securing product registrations, encompassing Generic, Branded Generic, and NDA approvals.
He excels in liaising with Health Authorities for compliance with GMP, GCP, Clinical Trials, BE studies, and literature surveys, while efficiently managing activities with CRO's and Ethical Committees on clinical projects.
Paulo Agra's proficiency extends to Intellectual Property management, where he handles Patents and Trademarks strategically for brand protection and research purposes.
He has established robust regulatory interfaces with Health Authorities and prominent Industry Associations, underscoring his commitment to integrity and compliance both internally and externally.
Paulo Agra's educational background includes extensive studies in Project Management, Pharmaceutical Technology, Industrial Pharmacy, Biochemistry, and Pharmaceutical Sciences from reputable institutions like Fundação Getulio Vargas, Universidade Federal do Rio de Janeiro, Universidade Federal de Goiás, Universidade Federal da Paraíba, and Universidade Estadual da Paraíba.
His notable past roles include Regulatory Affairs & Packaging Development Director at Abbott, Senior Director Regulatory Affairs at GSK Consumer Healthcare, Regulatory Affairs Manager & Compliance Officer OTC Mercosur at Novartis Consumer Health, Research-Development & Innovation Manager at Cristália Produtos Químicos e Farmaceuticos Ltda., Regulatory Affairs Manager at Laboratório Neo Química Com. e Ind. Ltda., and Senior Regulatory Affairs Specialist at ANVISA.
