About the job
Prepares, review 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 local regulatory strategy advice (MoH &/or EC) to internal clients.
Develops and implements local submission strategy. Provides 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 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.
Prepares the regulatory compliance review packages, as applicable.
Liaise within SIA locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.
Develops country specific Patient Information Sheet/Informed Consent form documents.
May assist with grant budgets(s) and payment schedules negotiations with sites.
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.
Ensures that trial status information relating to SIA activities are accurately maintained in the database and is current at all times.
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/mentos other SIA individuals assigned to support projects of responsibility, as appropriate
Proactively identifies issues or anomalies in the regulatory process of a study, resolves or escalates as appropriate
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