Job Title: Regulatory Diagnostics Associate Director – Precision Diagnostics
Company: Novartis Pharmaceuticals Corporation
Location: Cambridge, MA / East Hanover, NJ, USA (Hybrid)
Job Type: Full-Time | Senior Level | Research & Development
Job ID: REQ-10067179
About Novartis:
Novartis is a global pharmaceutical leader committed to improving patient outcomes through innovation in medicines and diagnostics. Our Precision Diagnostics team drives the development and regulatory approval of Companion Diagnostics (CDx) and in vitro diagnostic assays (IVDs), enabling personalized medicine and improved therapeutic strategies.
Role Overview:
The Regulatory Diagnostics Associate Director (RDAD) will lead regulatory strategies and implementation for precision diagnostics and CDx programs. This role provides technical and tactical regulatory guidance for clinical trial assays, ensuring compliance with global regulations and supporting the Novartis innovative medicines portfolio. The RDAD works closely with internal teams, including Regulatory Affairs, Digital, Data & Clinical Innovation (DDCI), and external partner companies to ensure regulatory alignment throughout development and commercialization.
Key Responsibilities:
Regulatory Strategy & Implementation
Develop and execute regulatory strategies for precision IVDs and CDx across key markets including the US, EU, Japan, and China.
Lead premarket and post-market submissions, including IDEs, Significant Risk Determinations, Performance Study Applications (PsA), and pre-market authorizations.
Integrate diagnostic regulatory requirements into early and late-stage drug development strategies.
Prepare and finalize briefing documents for regulatory authorities and coordinate meetings as necessary.
Manage timely responses to regulatory authority queries and follow-up activities.
Training & Compliance
Support compliance activities for clinical trials in accordance with global regulations for precision diagnostics and CDx, including EU IVDR.
Performance Indicators
Successful execution of regulatory diagnostics strategies with timely submissions.
Full compliance with IVD and CDx regulations across Novartis programs.
Required Experience & Qualifications:
BS or MS in Life Sciences or related field; advanced degrees (MS, PhD, PharmD) preferred.
Minimum 4–6 years of experience in the pharmaceutical, diagnostics, IVD, or CDx industry.
Proven experience contributing to regulatory projects for IVD/CDx development.
Knowledge of IDE, MAA, NDA/BLA, 510(k), PMA submissions.
Understanding of assay validation, CLIA requirements, and clinical trial processes.
Strong interpersonal, communication, and negotiation skills.
Compensation & Benefits:
Salary Range: $145,600 – $270,400 per year, dependent on skills and experience.
Performance-based incentives and eligibility for annual equity awards.
Comprehensive US benefits package including health, life, disability coverage, 401(k) with company match, paid vacation, personal days, and holidays.
Why Join Novartis:
Lead innovative regulatory strategies for precision diagnostics and personalized medicine.
Collaborate with global teams across drug development, diagnostics, and clinical innovation.
Access professional growth opportunities in a purpose-driven, patient-focused organization.
Contribute to cutting-edge scientific initiatives that improve patient outcomes worldwide.
Equal Opportunity & Accessibility:
Novartis is an Equal Opportunity Employer. We provide reasonable accommodations for individuals with disabilities and do not discriminate based on legally protected characteristics.
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