Regulatory Diagnostics Manager/ Senior Regulatory Diagnostics Manager

Role Summary

The Regulatory Diagnostics Manager (RDM)/Sr.Manager (Sr RDM) 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 RDM 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 RDM 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 and CDx (e.g. US, EU, Japan, China).
• With support of the RA TA and Diagnostics Lead, 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
• With oversight of the RA TA and Diagnostics Lead, 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
• As needed, partner with RA country organizations to align on local regulatory requirements for precision IVDs and CDx and deliver timely submissions as appropriate including annual reports and notifications
• 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.
• Member of RA sub team and Biomarker Development Subteam (BDST) as appropriate

Qualifications

• Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MS, Ph D, PharmD) considered a plus.
• Minimum 2-4 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) and/or submission
• 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 skills

Skills

• Regulatory strategy development and implementation
• Cross-functional collaboration with RA, DDCI, and partner teams
• Regulatory submissions andHA interactions
• Project planning and management

Education

• Science-based BS or MS (advanced degree preferred)

Additional Requirements

• Senior Manager: 4-6 years of relevant experience; demonstrates ability to lead regulatory projects