Regulatory Diagnostics Manager / Senior Regulatory Diagnostics Manager

Job Description Summary

The Regulatory Diagnostics Manager (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.

Job Description

Key Responsibilities

Regulatory Strategy and Implementation

• 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 subteam and Biomarker Development Subteam (BDST) as appropriate

Training and Compliance

Performance Indicators

Essential Requirements

Demonstrated experience of successfully contributions to a IVD / CDx regulatory project(s) and / or submission

Senior Manager :

Demonstrated experience of successfully contributions to a IVD / CDx regulatory project(s)

The pay range for this position at commencement of employment is expected to be between $114,100 and $211,900 (Manager) and $145,600 and $270,400 (Sr. Manager) per year; however, while salary ranges are effective from 1 / 1 / 25 through 12 / 31 / 2025, fluctuations in the job market may necessitate adjustments to pay ranges during this period. Further, final pay determinations will depend on various factors, including, but not limited to geographical location, experience level, knowledge, skills and abilities. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and / or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an "at-will position" and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department / team performance, and market factors.

Why Novartis

Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients' lives. Ready to create a brighter future together?

Benefits and Rewards

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EEO Statement : The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to us.reasonableaccommodations@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range $114,100.00 - $211,900.00

Skills Desired Clinical Trials, Detail-Oriented, Drug Development, Lifesciences, Negotiation Skills, Regulatory Compliance