Novartis
Regulatory Diagnostics Manager/ Senior Regulatory Diagnostics Manager
Novartis, East Hanover, New Jersey, us, 07936
Overview
Regulatory Diagnostics Manager/ Senior Regulatory Diagnostics Manager for Precision Diagnostics is responsible for implementing 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 on strategies and submissions (including CDx), in close collaboration with internal RA Disease Unit associates, Digital, Data and Clinical Innovation (DDCI) teams, and Partner Companies that develop diagnostics, ensuring adherence to regulatory requirements. The RDM provides regulatory support including tactical and technical regulatory direction for clinical trial assays to ensure compliance with regulations on diagnostics. Key Responsibilities
Regulatory Strategy and Implementation: support the diagnostics regulatory strategy for precision IVDs and CDx (e.g. US, EU, Japan, China). With support from the RA TA and Diagnostics Lead, manage submissions in premarket and post-market spaces including IDEs, Significant Risk Determinations, PsA and pre-market authorization submissions. Ensure diagnostic regulatory input for early development and late-stage programs is incorporated into the overall drug development strategy to meet IVD, CDx and LDT regulatory requirements. Partner with RA country organizations to align on local regulatory requirements for precision IVDs and CDx and deliver timely submissions (annual reports/notifications as appropriate). Coordinate and prepare briefing books and plan pre-submission or HA meetings related to precision diagnostics and CDx development; participate in HA meetings as appropriate. Develop, manage, and implement plans for timely responses to HA requests and follow-up activities. Participate as a member of the RA subteam and Biomarker Development Subteam (BDST) as appropriate. Training and Compliance: support compliance activities for Novartis clinical trials with global regulations on precision diagnostics and CDx; ensure regulatory compliance of Partner companies for CDx development and IVD deliverables as appropriate; support rollout of procedures, SOPs and training related to IVD and CDx development. Performance Indicators: successful implementation of regulatory diagnostics strategies with timely submissions for precision IVDs and CDx; full compliance with IVD and LDT rules for clinical trials; identification of precision IVD and CDx needs for Novartis programs; strong partnership with RA Diagnostics Team and the RA community; adherence to Novartis policies and guidelines. Essential Requirements
Science-based BS or MS with requisite experience; advanced degree (MS, PhD, PharmD) considered a plus. Minimum 2-4 years of experience in the pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development. Demonstrated experience contributing to an IVD/CDx regulatory project(s) and/or submission. Experience in the diagnostic, IVD and/or CDx industry. Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions; assay validation and CLIA; clinical trials. Strong interpersonal, communication and negotiation skills. Senior Manager Requirements
Science-based BS or MS with requisite experience; advanced degree (MS, PhD, PharmD) considered a plus. Minimum 4-6 years of experience in the pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development. Demonstrated experience contributing to an IVD/CDx regulatory project(s); experience in the diagnostic, IVD and/or CDx industry. Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions; assay validation and CLIA; clinical trials; strong interpersonal, communication and negotiation skills. IsExpired: false 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.
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Regulatory Diagnostics Manager/ Senior Regulatory Diagnostics Manager for Precision Diagnostics is responsible for implementing 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 on strategies and submissions (including CDx), in close collaboration with internal RA Disease Unit associates, Digital, Data and Clinical Innovation (DDCI) teams, and Partner Companies that develop diagnostics, ensuring adherence to regulatory requirements. The RDM provides regulatory support including tactical and technical regulatory direction for clinical trial assays to ensure compliance with regulations on diagnostics. Key Responsibilities
Regulatory Strategy and Implementation: support the diagnostics regulatory strategy for precision IVDs and CDx (e.g. US, EU, Japan, China). With support from the RA TA and Diagnostics Lead, manage submissions in premarket and post-market spaces including IDEs, Significant Risk Determinations, PsA and pre-market authorization submissions. Ensure diagnostic regulatory input for early development and late-stage programs is incorporated into the overall drug development strategy to meet IVD, CDx and LDT regulatory requirements. Partner with RA country organizations to align on local regulatory requirements for precision IVDs and CDx and deliver timely submissions (annual reports/notifications as appropriate). Coordinate and prepare briefing books and plan pre-submission or HA meetings related to precision diagnostics and CDx development; participate in HA meetings as appropriate. Develop, manage, and implement plans for timely responses to HA requests and follow-up activities. Participate as a member of the RA subteam and Biomarker Development Subteam (BDST) as appropriate. Training and Compliance: support compliance activities for Novartis clinical trials with global regulations on precision diagnostics and CDx; ensure regulatory compliance of Partner companies for CDx development and IVD deliverables as appropriate; support rollout of procedures, SOPs and training related to IVD and CDx development. Performance Indicators: successful implementation of regulatory diagnostics strategies with timely submissions for precision IVDs and CDx; full compliance with IVD and LDT rules for clinical trials; identification of precision IVD and CDx needs for Novartis programs; strong partnership with RA Diagnostics Team and the RA community; adherence to Novartis policies and guidelines. Essential Requirements
Science-based BS or MS with requisite experience; advanced degree (MS, PhD, PharmD) considered a plus. Minimum 2-4 years of experience in the pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development. Demonstrated experience contributing to an IVD/CDx regulatory project(s) and/or submission. Experience in the diagnostic, IVD and/or CDx industry. Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions; assay validation and CLIA; clinical trials. Strong interpersonal, communication and negotiation skills. Senior Manager Requirements
Science-based BS or MS with requisite experience; advanced degree (MS, PhD, PharmD) considered a plus. Minimum 4-6 years of experience in the pharmaceutical industry with relevant experience related to diagnostics, IVD or CDx development. Demonstrated experience contributing to an IVD/CDx regulatory project(s); experience in the diagnostic, IVD and/or CDx industry. Understanding of IDE, MAA, NDA/BLA, 510(k), PMA submissions; assay validation and CLIA; clinical trials; strong interpersonal, communication and negotiation skills. IsExpired: false 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.
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