Regulatory Affairs leader with diverse background in regulatory submissions, development strategy, and clinical operations. Over 25 years of experience spanning small molecules, biologics, and medical devices. Therapeutic areas include respiratory, oncology, inflammation, dermatology, and orthopedics. Professional skilled in communications with national and international regulatory agencies, clinical trial management and development of cohesive regulatory and clinical development strategies from Phase 1 through approval. Strengths include leadership, planning, execution under deadline pressure and strong organizational skills. Team player with excellent interpersonal communication and problem solving skills.