Metro New York & Southern Connecticut

Serves as the primary specialist on regulatory affairs processes for all types of clinical research studies, including high acuity trials. Maintains knowledge of changing regulations and policies governing clinical research and assesses the impact of such changes on the regulatory affairs department. Provides critical input into modified workflows and policies to address changes. Manages, implements, and evaluates all aspects of regulatory activities and strategies including submissions and responses at time of study initiation, execution/maintenance and close out. Interprets and applies regulations, policies and procedures to advise others on regulatory and compliance matters. Utilizes regulatory expertise and employs regulatory strategy to provide technical review of and draft required r