Regulatory Diagnostics Associate Director

Regulatory Diagnostics Associate Director

The Regulatory Diagnostics Associate Director 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.

Key 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 :

Performance Indicators :

Essential Requirements :

Salary Range : $145,600.00 - $270,400.00

Skills Desired : Clinical Trials, Cross-Functional Teamwork, Detail-Oriented, Drug Development, Group Problem Solving, Life Science, Negotiation, Regulatory Compliance, Risk Management