Hiring: Director, Regulatory Affairs, Companion Diagnostics Company: Daiichi Sankyo Location: Basking Ridge, NJ Job Posted Time: 2026-09-15 14:01:08 Target Skills & Keywords : Risk Management About the job Experience: •7+ years relevant pharmaceutical experience including experience within Regulatory Affairs required Required Skills: •Leadership responsibility for global regulatory strategy to support the development of biomarkers, companion diagnostic tests and other devices to enhance the value of our oncology pharmaceutical products. Provides innovative approaches to resolve complex regulatory issues and increase speed to patients. •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 •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. •Use of CTA/CDx within clinical trials •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. Qualifications: •Bachelor's Degree preferably in a scientific discipline required •Advanced degree (e.g., Masters, Pharm.D., Ph.D., MD preferred •Understanding of scientific content and complexities and good knowledge of diagnostic development, including extensive experience of IDE submissions and approvals required •Extensive experience developing companion diagnostics and devices required •Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization process required •Demonstrated capacity to travel up to 10% of the time. Occasional travel to Health Authority meetings in US and Europe, potentially Japan. •Daiichi Sankyo, Inc. is an equal opportunity/affirmative action employer. Qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected veteran status, age, or any other characteristic protected by law. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!