Regulatory Affairs Specialist

RCR Specialist, Regulatory Compliance Review, Regulatory Affairs Review RCR packages Respond to RCR reviewers/submitters on queries on essential documents Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams Ensure effective management and coordination of the Regulatory Compliance Review Process Management of the RCR reviewer allocation process to ensure rapid package review and minimal impact on project timelines Tracking of RCR package status across all projects to ensure that contingency planning is in place where necessary of RCR approvals Analysis of package results and review of audit reports to identify trends and recurrent deficiencies – implementation of measures to address Preparation of RCR metrics for presentation to management Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided Perform global regulatory compliance review of essential documents supporting the start of clinical studies

Perform other duties as requiredRCR Specialist, Regulatory Compliance Review, Regulatory Affairs Review RCR packages Respond to RCR reviewers/submitters on queries on essential documents Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams Ensure effective management and coordination of the Regulatory Compliance Review Process Management of the RCR reviewer allocation process to ensure rapid package review and minimal impact on project timelines Tracking of RCR package status across all projects to ensure that contingency planning is in place where necessary of RCR approvals Analysis of package results and review of audit reports to identify trends and recurrent deficiencies – implementation of measures to address Preparation of RCR metrics for presentation to management Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided Perform global regulatory compliance review of essential documents supporting the start of clinical studies

Perform other duties as requiredRCR Specialist, Regulatory Compliance Review, Regulatory Affairs Review RCR packages Respond to RCR reviewers/submitters on queries on essential documents Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams Ensure effective management and coordination of the Regulatory Compliance Review Process Management of the RCR reviewer allocation process to ensure rapid package review and minimal impact on project timelines Tracking of RCR package status across all projects to ensure that contingency planning is in place where necessary of RCR approvals Analysis of package results and review of audit reports to identify trends and recurrent deficiencies – implementation of measures to address Preparation of RCR metrics for presentation to management Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided Perform global regulatory compliance review of essential documents supporting the start of clinical studies

Perform other duties as requiredRCR Specialist, Regulatory Compliance Review, Regulatory Affairs Review RCR packages Respond to RCR reviewers/submitters on queries on essential documents Where required/applicable, facilitate discussion of requirement of deviation to the RCR process with the project teams Ensure effective management and coordination of the Regulatory Compliance Review Process Management of the RCR reviewer allocation process to ensure rapid package review and minimal impact on project timelines Tracking of RCR package status across all projects to ensure that contingency planning is in place where necessary of RCR approvals Analysis of package results and review of audit reports to identify trends and recurrent deficiencies – implementation of measures to address Preparation of RCR metrics for presentation to management Maintain knowledge and understanding of PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided Perform global regulatory compliance review of essential documents supporting the start of clinical studies

Perform other duties as required