Accountable for creation and implementation of regulatory strategy for products or indications.
Develop and oversee department policies and procedures to achieve department and corporate goals.
Provide leadership for product teams and direction to senior management on global regulatory strategy for all drug development programs.
Articulate complex regulatory issues to project teams and external stakeholders to support global development and commercialization of drug candidates.
Accountable for management of interactions and communications with FDA and ex-US regulatory authorities with the goal of achieving company objectives.
