Robert Shumaker Email and Phone Number

Extensive direct and administrative experience addressing a range of pre-clinical, regulatory affairs, clinical, and, product development challenges in the pharmaceutical industry. Proven competence authoring peer-reviewed publications in the areas of clinical and pre-clinical pharmacology, pathology, computer programming, organic synthesis, and, clinical and pre-clinical pharmacokinetics. Demonstrated ability forming, staffing and managing pre-clinical and clinical development teams. Demonstrated ability for budgeting, preparing and meeting time-lines, selecting and directing contract research organizations. Prepared relevant portions of biowaivers, ANDAs, NDAs, MAAs. Managed analytical and formulation development groups. Experienced with directly interacting with US, Canadian, European, and Mexican Regulatory Authorities.