Novartis
Regulatory Diagnostics Associate Director
The Regulatory Diagnostics Associate Director (RDAD) for Precision Diagnostics is responsible for implementing strategic plans for development of diagnostics, including Companion Diagnostics (CDx) as they pertain to Novartis’ innovative medicines portfolio, including its marketed products. The RDAD works with senior members of the Regulatory Affairs Precision Diagnostics Team, including the TA and Diagnostics Lead, on strategies and submissions for companion diagnostics in close collaboration with internal RA Disease Unit associates, associates of Digital, Data and Clinical Innovation (DDCI) at Novartis, and partner companies that develop diagnostics, ensuring adherence to regulatory requirements. The RDAD also provides regulatory support and tactical and technical direction for clinical trial assays to ensure compliance with diagnostic regulations.
Key Responsibilities
Supports the diagnostics regulatory strategy for precision in vitro diagnostic devices (IVDs) and companion diagnostics (CDx) in regions such as the US, EU, Japan, and China.
Manages submissions in the pre‑market and post‑market space, including Investigational Device Exemptions (IDE), Significant Risk Determinations, Performance Study Applications (PsA), and pre‑market authorization submissions.
Ensures diagnostic regulatory input for early development and late‑stage programs is incorporated into the overall drug development strategy, meeting all IVD, CDx, and LDT regulatory requirements.
Facilitates preparation, filing, and finalization of briefing books and coordinates planning for pre‑submission and other meetings with health authorities (HAs) related to precision diagnostics and CDx development. Participates in HA meetings as appropriate.
Develops, manages, and implements plans for timely responses to HA requests and coordinates any required follow‑up activities.
Supports compliance activities for Novartis clinical trials related to global precision diagnostics regulations such as the European In‑Vitro Diagnostic Regulation (IVDR).
Performance Indicators
Successful implementation of regulatory diagnostic strategies with timely submissions for precision IVDs and CDx and identification of precision IVD and CDx needs for Novartis programs.
Full compliance with IVD and LDT rules for clinical trials.
Key Qualifications
Science‑based BS or MS with requisite experience and demonstrated capability (advanced degree such as MS, PhD, or PharmD considered a plus).
Minimum 4–6 years of experience in the pharmaceutical industry with relevant diagnostics, IVD, or CDx development experience.
Demonstrated success on at least one IVD/CDx regulatory project.
Experience within the diagnostic, IVD, and/or CDx industry.
Strong understanding of IDE, MAA, NDA/BLA, 510(k), and PMA submissions.
Strong understanding of assay validation and CLIA.
Strong understanding of clinical trials.
Excellent interpersonal, communication, and negotiation skills.
Salary is expected to range between $145,600 and $270,400 per year. The final salary offered depends on relevant skills and experience; upon joining, Novartis will review compensation periodically. The role includes a performance‑based cash incentive and, depending on the level, eligibility for annual equity awards.
US‑based eligible employees will receive a comprehensive benefits package that includes health, life, and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays, and other leaves.
Why Novartis Helping people with disease and their families takes more than innovative science; it requires a community of smart, passionate people. Collaborating, supporting, and inspiring each other leads to breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards Read our handbook to learn about the ways we help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement The Novartis Group of Companies is an Equal Opportunity Employer. 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 & Reasonable Accommodations Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation for any part of the application process or to perform essential functions, please email talentmentoring@novartis.com or call +1(877)395-2339. Include the job requisition number in your message.
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Key Responsibilities
Supports the diagnostics regulatory strategy for precision in vitro diagnostic devices (IVDs) and companion diagnostics (CDx) in regions such as the US, EU, Japan, and China.
Manages submissions in the pre‑market and post‑market space, including Investigational Device Exemptions (IDE), Significant Risk Determinations, Performance Study Applications (PsA), and pre‑market authorization submissions.
Ensures diagnostic regulatory input for early development and late‑stage programs is incorporated into the overall drug development strategy, meeting all IVD, CDx, and LDT regulatory requirements.
Facilitates preparation, filing, and finalization of briefing books and coordinates planning for pre‑submission and other meetings with health authorities (HAs) related to precision diagnostics and CDx development. Participates in HA meetings as appropriate.
Develops, manages, and implements plans for timely responses to HA requests and coordinates any required follow‑up activities.
Supports compliance activities for Novartis clinical trials related to global precision diagnostics regulations such as the European In‑Vitro Diagnostic Regulation (IVDR).
Performance Indicators
Successful implementation of regulatory diagnostic strategies with timely submissions for precision IVDs and CDx and identification of precision IVD and CDx needs for Novartis programs.
Full compliance with IVD and LDT rules for clinical trials.
Key Qualifications
Science‑based BS or MS with requisite experience and demonstrated capability (advanced degree such as MS, PhD, or PharmD considered a plus).
Minimum 4–6 years of experience in the pharmaceutical industry with relevant diagnostics, IVD, or CDx development experience.
Demonstrated success on at least one IVD/CDx regulatory project.
Experience within the diagnostic, IVD, and/or CDx industry.
Strong understanding of IDE, MAA, NDA/BLA, 510(k), and PMA submissions.
Strong understanding of assay validation and CLIA.
Strong understanding of clinical trials.
Excellent interpersonal, communication, and negotiation skills.
Salary is expected to range between $145,600 and $270,400 per year. The final salary offered depends on relevant skills and experience; upon joining, Novartis will review compensation periodically. The role includes a performance‑based cash incentive and, depending on the level, eligibility for annual equity awards.
US‑based eligible employees will receive a comprehensive benefits package that includes health, life, and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Employees are also eligible for a generous time‑off package including vacation, personal days, holidays, and other leaves.
Why Novartis Helping people with disease and their families takes more than innovative science; it requires a community of smart, passionate people. Collaborating, supporting, and inspiring each other leads to breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture
Benefits and Rewards Read our handbook to learn about the ways we help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement The Novartis Group of Companies is an Equal Opportunity Employer. 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 & Reasonable Accommodations Novartis is committed to providing reasonable accommodations to individuals with disabilities. If you need an accommodation for any part of the application process or to perform essential functions, please email talentmentoring@novartis.com or call +1(877)395-2339. Include the job requisition number in your message.
#J-18808-Ljbffr