Provide an objective commercial viewpoint of potential disruptive forces and pending market and competitive drivers, based on an in-depth understanding and analysis of healthcare dynamics, commercial, clinical and scientific competitive information.
Responsible for preform/formulation, and other development studies including prototype stability, dose handling-administration, extractable/leachables, packaging, investigations and/or process qualifications to support GMP compliance and regulatory submissions.
Develops the global regulatory strategy for individual programs including preparing the programs for successful registration in all major global markets.
