Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
-Prepares, reviews and coordinates local regulatory submissions and strategies (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.
• -Technical expertise and coordination oversight for projects in collaboration with relevant internal
departments.
• Serves as primary contact for investigators and with the local regulatory
authorities (in collaboration with the local regulatory manager for complex
issues) to ensure submissions are managed in a timely manner.
• Ensures guidelines and processes are followed for effective internal PPD team
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communications as well as communications with investigators, and with the
country regulatory authorities to ensure submissions are managed in a timely
manner.
• Acts as a key-contact at country level for all submission-related activities.
• Participates as required in Submission Team Meetings, Review Meetings and
Project Team meetings.
• 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 submission process for sites and study are
aligned to the critical path for site activation.
• Achieves PPD's target cycle times for site activations.
• Works with the start-up CRA(s) to prepare the regulatory compliance review
packages, as applicable.
• Assists in identifying and recognizing local out of scope activities in a contract in
a timely manner and advise relevant functions.
• Supports the coordination of feasibility activities, as required, in accordance with
agreed timelines.
• Oversees country study files and ensures that that they meet PPD WPD's or
client SOP's.
• Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.
Directs/mentors other SIA individuals assigned to support projects of responsibility, as appropriate.
Prepares and maintains country master document templates and other PPD
regulatory intelligence systems, as may be required and assigned.