New Taipei City, New Taipei City, Taiwan
Handled drug product life cycle management, including NDAs and INDs, plus CRO management. As a task force/expert in new regulatory information systems and other processes. As a mentor to the newcomers.
Regulatory affair on product lifecycle management and CTA/IND.
NDA • Minority/priority designation • Strategy discussion • NDA whole submissions CRO management • Monitoring CRO to handle the mature brand products • Make sure all submissions and approvals are achieved. Regulatory renewal submission • Drug license • PMF renewal • Drug import license Variation submission • Indication addition • Labeling update • Insert/label/carton artwork and manufacture arrangement • PI translation/typewriting arrangement • DMF amendment • Site transfer • Regulatory system update PMF management • PMF registration • PMF variation
Clinical trial submission • New clinical trial application (IND) • Revised Protocol • Administrative letter notification • IB update notification • Drug/Lab kit import permit application • Sample export permit application • Sites closure / increase application • Investigator / sub-investigator change or increase application • Clinical study report submission & GCP inspection operation • Review proforma invoice of study drug • Taiwan IND list update • Taiwan drug import permit summary update License renewal submission • License renewal • Site renewal Variation submission • Labeling update • Insert / label / carton artwork and manufacture arrangement • PI translation / typewriting arrangement • Regulatory system update
• Perform site selection, monitoring and close-out visits in accordance with contracted scope of work and good clinical practice. • Provide monitoring visits and site management for a variety of protocols, sites and therapeutic areas (almost cancer therapy). • Administer protocol and related study training to assigned sites and establish regular lines of communication with sites to manage ongoing project expectations and issues. • Evaluate the quality and integrity of study site practices related to the proper conduct of the protocol and adherence to applicable regulations. Escalate quality issues to Clinical Project Manager (CPM), Clinical Research Specialist (CRS) and/or line manager. • Manage the progress of assigned studies by tracking regulatory submissions and approvals, recruitment and enrollment, case report form (CRF) completion and submission, and data query generation and resolution. • Create and maintain appropriate documentation regarding site management, monitoring visit findings and action plans by submitting regular visit reports, generating follow-up letters and other required study documentation.