Clinical Trial Reg Affairs Specialist Ii

Prepares and reviews regulatory submissions- Provides regulatory strategy as support RAL and RAL and/or technical advice to internal and external clients and acts as a liaison in executing strategies.- Leads the development and implementation of project-specific processes for sponsors.- Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.- Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.- Provides training and guidance to junior team members as appropriate.- Participates in project launch meetings, review meetings and project team meetings.- Supports business development activities, including project budgeting/forecasting.