Regulatory Diagnostics Associate Director

Role Summary

The Regulatory Diagnostics Associate Director (RDAD) for Precision Diagnostics is responsible for implementation of strategic plans for development of diagnostics, including Companion Diagnostics (CDx), as they pertain to the Novartis innovative medicines portfolio, including its marketed products. The RD Associate Director works with oversight of senior members of the Regulatory Affairs Precision Diagnostics Team including the TA and Diagnostics Lead on strategies and submissions including companion diagnostics, in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis as well as Partner Companies that develop diagnostics and ensures adherence to regulatory requirements. The RD Associate Director will also provide regulatory support including tactical and technical regulatory direction for clinical trial assays to ensure compliance with regulations on diagnostics.

Responsibilities

• Supports the diagnostics regulatory strategy for precision IVDs (In Vitro Diagnostic) and CDx (e.g. US, EU, Japan, China).
• Responsible for submissions in the premarket as well as post-market space including investigational Device Exemptions (IDE), Significant Risk Determinations, Performance Study Applications (PsA) and pre-market authorization submissions.
• Works to ensure diagnostic regulatory input for early development and late- stage programs is incorporated into the overall drug development strategy to ensure regulatory requirements pertaining to IVD, CDx and LDT regulations are met.
• Facilitates preparation, filing, finalization of briefing books including coordination and planning for pre-Submission or other meetings with HAs related to precision diagnostics and CDx development. Participation in HA meetings as appropriate.
• Develops, manages, and implements plans for timely response to HA requests and coordinates of any applicable follow-up activities.

Training and Compliance

• Support compliance activities for Novartis clinical trials as they relate to global regulations on precision diagnostics and CDx, such as European IVDR (In Vitro Diagnostic Regulation).

Performance Indicators

• Successful implementation of regulatory diagnostics strategies with timely submissions for precision IVDs and CDx and identification of precision IVD and CDx needs for Novartis programs.
• Full compliance with IVD and LDT rules for our clinical trials.

Qualifications

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MS, Ph D, PharmD) considered a plus.
• Minimum 4-6 years of experience in pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development
• Demonstrated experience of successfully contributions to a IVD/CDx regulatory project(s)
• Experience in the diagnostic, IVD and/or CDx industry
• Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submission(s)
• Understanding of assay validation and CLIA
• Understanding of clinical trials
• Strong interpersonal, communication and, negotiation skill