Job Description

Position Overview

This role involves preparing, reviewing, and coordinating local regulatory submissions (MoH, EC, and other special national local applications) in alignment with global submission strategies. The position also offers guidance on local regulatory strategy advice (MoH &/or EC) to internal clients and provides project-specific local SSU services and coordination.

Employment Type

• Full-time

Work Schedule

• Standard (Mon-Fri)

Environmental Conditions

• Office

Responsibilities

• Prepares, reviews, and coordinates local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides, under guidance, local regulatory strategy advice (MoH & EC) to internal clients.
• Provides project specific local SSU services and coordination of these projects.
• May have contact with investigators for submission related activities.
• Serves as the key contact at the country level for either Ethical or Regulatory submission-related activities.
• Coordinates with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines.
• Ensures alignment of the submission process for sites and study with the critical path for site activation.
• Achieves PPD’s target cycle times for site.
• May work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
• May develop country-specific Patient Information Sheet/Informed Consent form documents.
• May assist with grant budgets and payment schedules negotiations with sites.
• Supports the coordination of feasibility activities, as the need arises, in accordance with agreed timelines.
• Enters and maintains trial status information relating to SIA activities onto PPD supervising databases in an accurate and timely manner.
• Ensures the local country study files and filing processes are prepared, set up, and maintained as per PPD WPDs or applicable client SOPs.
• Maintains knowledge of and understands PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Requirements

• (Specific requirements are not detailed in the provided text.)

Application Instructions

• (Application instructions are not detailed in the provided text.)

Company Information

• (Company information is not detailed in the provided text.)