PPD Regulatory Affairs Specialist in India, Indiana
The skill set would be forclinical trial applications/authorization/submissions/managementetc.. across EMEA, APAC, NA and LA regions
- Responsible for the coordination, preparation/compilation of documents/dossiers for regulatory (biological and chemical products) submission for Clinical Trial Applications to Heath Authorities in EMEA, APAC, NA and LA Countries.
Preparation of initial Clinical Trial Applications, Amendment Applications (Protocol, IB, and IMPD), Site Addition, Site Closure Notifications, Query responses and Global and Local End of Trial NotificationsReviewing the technical and scientific data and reports required for regulatory submission.
Co-ordinating with Global and Local team for the required documentations for the country submissions.
- Maintain regulatory files in a format consistent with requirements and Tracking the approvals.
- Supporting the submission of the observation study, Non-Interventional study, Surveillance study protocols.
- Registration of Clinical Trials in Clinical Trial Registries.
- Well experienced in handling the Health Authority submission portals. SUGAM (India), CESP, Eudralink and EudraCT database (EU)
Bachelors with 2 years of relevant experience preferred
Job: *Regulatory Affairs
Organization: *IN BU
Title: Regulatory Affairs Specialist
Requisition ID: 192546
PPD is an affirmative action employer that values diversity as a strength fosters and environment of mutual respect. PPD provides equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or other status within any other protected group
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