Job Description

Prepares, reviews and coordinates local regulatory submissions (MoH, EC and additional special national local applications if applicable) in alignment with the global submission strategy. Develops and implements the local submission strategy and provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments. Primary contact for investigators and for local regulatory authorities to ensure submissions are managed in a timely manner. Participates in Submission Team Meetings, Review Meetings and Project Team meetings as required. Ensures the submission process for sites and studies are aligned to the critical path for site activation. Prepares Regulatory Compliance Review packages, as applicable, as well as liaising within SIA locally to ensure the local submission activity is planned and delivered in accordance with the global project submission strategy. In addition, develops country and site specific Patient Information Sheet/Informed Consent form documents. Coordinates with internal functional departments, to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines. Ensures the submission process for sites and studies are aligned to the critical path for site activation. Has contact with investigators for submission related activities and serves as a key contact at country level for either Ethical or Regulatory submission related activities. Achieves PPD target cycle times for site. Prepares Regulatory Compliance Review packages, including working with the SIA CRA as applicable.