Daiichi Sankyo US · 2 days ago
Associate Director, CDx Regulatory Affairs
Basking Ridge, NJ
Full-time
Onsite
Mid, Senior Level, Lead/Staff
$138K/yr - $207K/yr
4+ years expDaiichi Sankyo US is dedicated to improving lives through innovative medicines, with a strong focus on oncology and other therapeutic areas. The Associate Director, CDx Regulatory Affairs will be responsible for developing regulatory strategies for companion diagnostics and ensuring compliance with global regulatory standards. This role involves collaboration with cross-functional teams and external partners to facilitate timely submissions and approvals for diagnostic products.
Health CareTherapeuticsWellness
Responsibilities
CDx development: Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for each country/region, both before and after CDx testing, for less complex projects
At the time of implementation of a CDx study/IVDR performance evaluation study & integration of an assay into clinical testing (before testing) and once data is ready for CDx submission (after testing)
Serve as the Point of Contact (PoC) for gathering country/region specific CDx RA requirements from local RA team members (e.g. from Japan, China, Australia, Canada, Korea etc.)
For recruitment in EU: It is critical that this person has, and continues to develop regulatory expertise on IVDR. This person will develop regulatory strategy and provide input on IVDR requirements to enable and support timely registration of both therapeutic and diagnostic products in the EU as well as UK and Switzerland
CDx RA Strategy: Align strategy with lead CDx RA representative(s) and represent Global CDx Regulatory position and provide input and updates within internal cross-functional teams (e.g., Diagnostic Development Teams) and to external diagnostic business partners specifically:
Use of CTA/CDx within clinical trials
Device protocols and SAPs
Device non-significant/significant risk determinations (both submission to CDRH in a Q-sub process and in a streamlined fashion within protocol submission to CDER via the INDs), IDEs
Biomarker strategies towards patient selection, patient stratification, bridging between CTA/CDx assays, prospective vs retrospective analyses and collection, missing data, demographic/representativeness of samples from clinical trial and screen failures
Clinical trial protocol development and reviews (clinical trial protocols and medical device protocols)
ICF reviews to ensure adequate disclosure for collection, retention, testing and retesting of samples
Project Team Participation: Provide device-specific regulatory insight/guidance during CDx Indication Team & Working Group (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to communicate key RA updates from the drug side, as needed. Provide RA specific inputs into CDx Risk Management plans for individual projects/indications. Assist the CDx team with the creation of contingency/backup plans for CDx submission
Health Authority Submission Preparation: Assist with preparation of pre-submission documents and CDx related portions of therapeutic marketing applications and respond to regulatory queries/feedback from HAs. Contribute to providing timely feedback for Dx Partners to address regulatory questions from Global Health Authorizes (HAs) during review of device submissions
In collaboration with CDx lead work with Dx partners to ensure robust development of assay, participate in HA interaction for drug-related CDx topics/questions, and attend device company HA meetings as appropriate
In collaboration with therapeutic Regulatory leads and CDx lead develop key questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side)
CDx RA Policy and Intelligence: Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these changes
Assessing the impacts of relevant drug and diagnostic regulations on the development and registration activities for the respective medical products
Qualification
Required
Bachelor's Degree required
4 or more years scientific background
Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals
Extensive experience developing companion diagnostics and devices
Experience of drug development and drug regulatory procedures
Understanding of strategic and tactical role and deliverables of Global Regulatory strategy in the drug and device development and commercialization process
Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
Experience with communicating the regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required
Preferred
Master's Degree or Advanced degree (PharmD, MD, PHD) preferred
Company
Daiichi Sankyo US
Daiichi Sankyo US is a pharmaceutical company delivering innovative research, solutions, and treatments to improve health.
10001+ employees
H1B Sponsorship
Daiichi Sankyo US has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (32)
2024 (25)
2023 (19)
2022 (12)
2021 (7)
2020 (6)
Funding
Current Stage
Late StageLeadership Team
Ken Keller
Chairman of the Board, President and CEO and Head of the Global Oncology Business Unit
Christopher Geloso
Senior Region Business Director - ADC Oncology at Daiichi Sankyo, Inc.
Recent News
2025-06-01
2025-02-18
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