Regulatory Diagnostics Manager/ Senior Regulatory Diagnostics Manager

Role Summary

The Regulatory Diagnostics Manager (RDM) or Senior Regulatory Diagnostics Manager (Sr RDM) for Precision Diagnostics is responsible for implementing strategic plans for the development of diagnostics, including Companion Diagnostics (CDx), as they pertain to the Novartis innovative medicines portfolio and marketed products. The role involves collaboration with senior members of the Regulatory Affairs Precision Diagnostics Team, internal partners, and external collaborators to ensure regulatory compliance and successful submissions. The RDM/Sr RDM provides regulatory direction for clinical trial assays and ensures adherence to regulatory requirements for diagnostics.

Responsibilities

• Supports the diagnostics regulatory strategy for precision IVDs and CDx (US, EU, Japan, China).
• With support from the RA TA and Diagnostics Lead, responsible for submissions in premarket and post-market spaces (IDE, Significant Risk Determinations, PsA, PMA submissions).
• Ensure diagnostic regulatory input for early development and late-stage programs is integrated into the overall drug development strategy to meet IVD, CDx, and LDT regulations.
• Partner with RA country organizations to align on local regulatory requirements for precision IVDs and CDx and deliver timely submissions, including annual reports and notifications.
• Facilitate preparation and filing of briefing books and coordinate pre-Submission meetings with health authorities for precision diagnostics and CDx development; participate in HA meetings as appropriate.
• Develop, manage, and implement plans for timely responses to HA requests and coordinate follow-up activities.
• Serve as a member of the RA sub team and Biomarker Development Subteam (BDST) as appropriate.

Training and Compliance

• Support compliance activities for Novartis clinical trials related to global regulations on precision diagnostics and CDx (e.g., European IVDR).
• Help ensure regulatory compliance of partner companies for CDx development and IVD deliverables; support roll-out of new procedures, SOPs, and training related to IVD/CDx development.

Performance Indicators

• Successful implementation of regulatory diagnostics strategies with timely submissions for precision IVDs and CDx.
• Full compliance with IVD and LDT rules for clinical trials.
• Identification of precision IVD/CDx needs for Novartis programs.
• Strong partnerships with RA Diagnostics Team members and the RA community; adherence to Novartis policies and guidelines.

Qualifications

• Essential: Science-based BS or MS with requisite experience; advanced degree (MS, PhD, PharmD) considered a plus.
• Essential: 2‚Äì4 years in the pharmaceutical industry with relevant experience related to diagnostics, IVD, or CDx development.
• Demonstrated experience contributing to an 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 submissions; assay validation and CLIA; clinical trials.
• Strong interpersonal, communication, and negotiation skills.

Skills

• Regulatory strategy development and execution for diagnostics and CDx
• Cross-functional collaboration with RA teams, disease units, and external partners
• Regulatory submissions and health authority interactions
• Project management and planning for complex regulatory programs

Education

• Science-based BS or MS required; advanced degree (MS, PhD, PharmD) preferred

Additional Requirements

• Experience with global regulatory environments for diagnostics required