Regulatory Diagnostics Manager/ Senior Regulatory Diagnostics Manager
Job ID: REQ-10046815
Date: April 14, 2025
Location: USA (Cambridge, MA or East Hanover, NJ)
Summary:
The Regulatory Diagnostics Manager (RDM) for Precision Diagnostics is responsible for implementing strategic plans for the development of diagnostics, including companion diagnostics (CDx), related to the Novartis innovative medicines portfolio. The RDM operates under the oversight of senior Regulatory Affairs Precision Diagnostics Team members and collaborates with internal and external partners to ensure adherence to regulatory requirements and provide regulatory support for clinical trial assays.
About the Role:
Key Responsibilities:
Regulatory Strategy and Implementation:
Support diagnostics regulatory strategy for precision IVDs and CDx in global regions (US, EU, Japan, China).
Responsible for submissions including IDE, Significant Risk Determinations, Performance Study Applications, and pre-market authorizations.
Ensure early and late-stage drug development strategies incorporate diagnostic regulatory input.
Collaborate with RA country organizations to align on local regulatory requirements and manage timely submissions.
Facilitate and finalize briefing books for health authority (HA) interactions; participate in HA meetings as needed.
Develop and manage plans for timely responses to HA requests and subsequent activities.
Serve as a member of the RA subteam and Biomarker Development Subteam (BDST) where applicable.
Training and Compliance:
Support compliance activities related to global regulations on precision diagnostics and CDx, including European IVDR.
Ensure regulatory compliance of partner companies for CDx development and deliverables.
Assist in rolling out new procedures, SOPs, working practices, and training related to IVD and CDx development.
Performance Indicators:
Successful regulatory strategy implementation and timely submissions.
Full compliance with IVD and LDT rules for clinical trials.
Identification and integration of precision IVD and CDx needs.
Strong collaboration with RA Diagnostics Team and RA community.
Adherence to Novartis policies and guidelines.
Essential Requirements:
For Manager Level:
Science-based BS or MS degree; Advanced degrees (MS, PhD, PharmD) are a plus.
2-4 years of pharmaceutical industry experience with relevance to diagnostics, IVD, or CDx development.
Proven contributions to IVD/CDx regulatory projects or submissions.
Experience in the diagnostic, IVD, and/or CDx industry.
Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions.
Knowledge of assay validation and CLIA regulations.
Understanding of clinical trial operations.
Strong interpersonal, communication, and negotiation skills.
For Senior Manager Level:
Science-based BS or MS degree; Advanced degrees (MS, PhD, PharmD) are a plus.
4-6 years of pharmaceutical industry experience with relevance to diagnostics, IVD, or CDx development.
Demonstrated experience with successful IVD/CDx regulatory project contributions.
Experience in the diagnostic, IVD, and/or CDx industry.
Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions.
Knowledge of assay validation and CLIA regulations.
Understanding of clinical trial operations.
Strong interpersonal, communication, and negotiation skills.
Compensation:
Manager Level Salary Range: $114,100 - $211,900/year
Senior Manager Level Salary Range: $145,600 - $270,400/year
Compensation may include sign-on bonuses, restricted stock units, discretionary awards, and a full range of benefits including 401(k) eligibility, paid time off, vacation, sick leave, and parental leave.
Final pay determinations depend on factors including geographical location, experience, skills, and abilities.
Why Novartis:
At Novartis, helping people with disease requires collaboration among smart, passionate individuals. Together, we achieve breakthroughs that change patients' lives. Join us to create a brighter future: About Novartis People & Culture
Benefits and Rewards:
Learn how we support your personal and professional growth: Benefits and Rewards Handbook
Join Our Network:
Stay connected to learn about future opportunities: Novartis Talent Network
EEO Statement:
The Novartis Group of Companies is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital status, veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations:
Novartis is committed to working with and providing reasonable accommodations to individuals with disabilities. For assistance, email: us.reasonableaccommodations@novartis.com or call +1(877)395-2339.
Additional Information:
Division: Development
Business Unit: Universal Hierarchy Node
Functional Area: Research & Development
Job Type: Full-Time
Employment Type: Regular
Shift Work: No
Company/Legal Entity: U014 (FCRS = US014) Novartis Pharmaceuticals Corporation
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