Job Description:
•Assist in the preparation of regulatory affairs documentation
•Prepare regulatory submissions, under guidance
•Review regulatory submissions, under guidance
•Liaise with internal and external clients in the tracking and status update of project plans
•Provide project specific GRA services and co-ordination of these projects
•Liaise with PPD globally to support global projects
•Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
•Assist with project budgeting/forecasting
•Assist in business development and pricing of projects for GRA in the company
•Other duties as required
•Assist in the preparation of regulatory affairs documentation
•Prepare regulatory submissions, under guidance
•Review regulatory submissions, under guidance
•Liaise with internal and external clients in the tracking and status update of project plans
•Provide project specific GRA services and co-ordination of these projects
•Liaise with PPD globally to support global projects
•Maintain knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided
•Assist with project budgeting/forecasting
•Assist in business development and pricing of projects for GRA in the company
•Other duties as required
