Regulatory Diagnostics Associate Director

East Hanover, NJ - USA

Yearly Salary: $ 145600 - 270400

Posted on: 9 days ago

Vacancies: 1 Vacancy

Job Summary

Job Description Summary

The Regulatory Diagnostics Associate Director (RDAD) 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 RD Associate Director 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 RD Associate Director will also provide regulatory support including tactical and technical regulatory direction for clinical trial assays to ensure compliance with regulations on diagnostics.

Job Description

#LI-Hybrid

Key Responsibilities:

Regulatory Strategy and Implementation

Supports the diagnostics regulatory strategy for precision IVDs (In Vitro Diagnostic) and CDx (e.g. US EU Japan China).
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.
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.
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.

Training and Compliance

Support compliance activities for Novartis clinical trials as they relate to global regulations on precision diagnostics and CDx such as European IVDR (In Vitro Diagnostic Regulation).

Performance Indicators

Successful implementation of regulatory diagnostics 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 our clinical trials.

Essential Requirements:

Science based BS or MS with requisite experience and demonstrated capability. Advanced degree (MS Ph D PharmD) considered a plus.
Minimum 4-6 years of experience in pharmaceutical industry with relevant experience related to diagnostics IVD or CDx development
- Demonstrated experience of successfully contributions to a IVD/CDx regulatory project(s)
- Experience in the diagnostic IVD and/or CDx industry
- Understanding of IDE MAA NDA/BLA 510(k) PMA submission(s)
- Understanding of assay validation and CLIA
- Understanding of clinical trials
- Strong interpersonal communication and negotiation skill

The salary for this position is expected to range between $145600 and $270400 per year.

The final salary offered is determined based on factors like but not limited to relevant skills and experience and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and depending on the level of the role eligibility to be considered 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 addition employees are eligible for a generous time off package including vacation personal days holidays and other leaves.

To learn more about the culture rewards and benefits we offer our people click here.

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 or call 1 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$145600.00 - $270400.00

Skills Desired

Clinical Trials Cross-Functional Teamwork Detail-Oriented Drug Development Group Problem Solving Life Science Negotiation Regulatory Compliance Risk Management

Required Experience:

Director

Job Description SummaryThe Regulatory Diagnostics Associate Director (RDAD) 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...