My passion is science and I offer a unique combination of exceptional technical knowledge and business competencies accumulated from over 25 years of experience in several roles such as a Federal Regulator (FDA), Corporate Regulatory Affairs Professional and a Clinical Pharmacology Professional. I have a wide breadth of expertise in managing global clinical trials and regulatory submissions towards marketing authorizations of new drugs, conducting research to direct regulatory strategy, and working collaboratively with major pharmaceutical organizations, contract research organizations (CRO’s), the FDA, and global health authorities.As a scientific leader, I am adept at providing project specific regulatory guidance, mentorship, training, and direction to global clinical and regulatory professionals, I have demonstrated success in supervising clinical and regulatory activities towards achieving marketability of new drugs.My goal is to bring my strong capabilities in coordinating, organizing, and managing complex clinical and regulatory functions/activities with global project teams towards optimizing novel drug development strategies within the Pharmaceutical and Biotechnology industry.Specialties: Regulatory affairs, Clinical Pharmacology, FDA/EMA and Global Health Authorities, IND/NDA/BLA/MAA filing and regulatory review, regulatory negotiation strategies, Strategic Planning, Execution/Integration, Regulatory Science and Research, Regulatory Policy and Guidance, Clinical Pharmacology research, Translational research.