A performance-driven regulatory affairs professional with a diverse background and extensive scientific and regulatory experience, including that of a former FDA reviewer, utilizing innovative global regulatory strategy and decision making, resulting in an effectual implementation for early and late product development and lifecycle management. These regulatory responsibilities and competencies are complemented by additional training and development experiences, including clinical pharmacology, nonclinical pharmacology and toxicology, quality assurance/compliance, technical writing and project management. Together these are a foundation for assessing regulatory risk, facilitating knowledgeable team decision making and innovative ***** /biotech product development through registration and approval, with more than 25 NDA, BLS, MAA and NDS applications. Proven track record of establishing or maintaining a collaborative relationship with the FDA and other international regulatory agencies, including the Europe, North America, Asia-Pacific.
Demonstrated effective management, leadership, and communication skills, with strategic insight, operational excellence, novel analytical problem-solving and thinking outside of the box mentality, solid team player with interpersonal skills, including motivating, mentoring and developing more junior professionals in their professional and career development.