Michele Hardy Email and Phone Number

I am a senior regulatory professional with extensive experience interacting with and advising all levels of management, including C-suite, on regulatory matters relating to development and commercialization of prescription drugs. I have built and maintained effective work relationships with staff and management within FDA, which have helped the organization achieve company objectives. I thrive in fluid, high-pressure situations and excel when partnering across organizational boundaries to create value and deliver results.I have solid experience in key areas of drug development with particular expertise in drug labeling and advertising, including product launches.My strengths include issues analysis with business-focused resolution, understanding and interpreting prescription drug promotion regulations, building regulatory organizations that exceed expectations, cultivating strong business partnerships, optimizing regulatory processes, and staff development.