Michael Schroeder, MS


Michael Schroeder, MS,brings over 30 years of regulatory affairs experience in operational and executive roles in both large established pharma companies and fast paced, entrepreneurial start-ups, including Sandoz (pre-Novartis), Hoechst-Roussel, Elan, Sano, DOV Pharmaceutical and QRxPharma. He has experience in a wide variety of therapeutic areas, including analgesia, psychiatry, neurology, drug abuse, anti-infectives, metabolic and endocrine, cardiovascular, oncology, dermatology, and women’s health. Proven strengths include effective FDA communications at all levels; developing regulatory and development strategies for successful milestone/phase transitions; managing content and preparation of pre-meeting briefing documents and preparation for face to face meetings with FDA and ex-US regulatory agencies; planning, compiling, and submitting large multi-country marketing applications (eCTDs) in a nearly virtual environment; and preparation and submission of FDA- and eCTD- compliant IND and NDA documents. Mike earned a MS in Environmental Sciences from the University of Virginia.

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