Sr. Ctry Approval Spec

Summarized Purpose :

Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

• Prepares, review and coordinates local regulatory submissions (EC, additional special national local applications if applicable, gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Provides local regulatory strategy advice (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.

Qualifications :

Education and Experience :

Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Previous experience that provides the knowledge, skills, and abilities to perform the job.

Knowledge, Skills and Abilities :

regulations