Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

Job Description

What will you do?

Participates in the management and preparation, review, and coordination of Country Submissions in line with global submission strategy.Under guidance, prepares, reviews, and coordinates local regulatory submissions (MoH and additional special national local applications as applicable) in alignment with the global submission strategy.Provides, under guidance local regulatory strategy advice (MoH) to internal clients.Works on various regulatory affairs including maintenance and application of clinical trials, regulatory problem solving, giving consultation of local regulatory requirements.Coordinates with internal functional departments, to ensure various site start-up activities are aligned with submission activities and mutually agreed upon timelines.In collaboration with other department, and in accordance with the Regulatory Authority Communication Policy, served as a contact with MoH for application activities.Compiles and submits initial applications, substantial amendments, periodic reports, and notification reports.May have contact with investigators for submission related activities.Achieves PPD’s target cycle times.Develops country specific labels and patient cards.Ensures and maintains trial status information relating to start-up activities onto PPD tracking databases in an accurate and timely manner.Ensures the local country study files and filing processes are prepared, set up and maintained as per TFS(PPD) SOP/WPDs or applicable client SOPs.Maintains knowledge of and understand TFS(PPD) SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Qualifications

Over 1+ years of MFDS IND experience.Have experience with MFDS initial submissions, amendment submissions, and notifications.Bachelor's degree or aboveAcademic background in Life Science, Nursing, Biology, Pharmaceutical Science are preferred.