CDx Associate Director, Global Regulatory Affairs
Location: Basking Ridge
Posted on: June 23, 2025
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Job Description:
Join a Legacy of Innovation 125 Years and Counting! Daiichi
Sankyo Group is dedicated to the creation and supply of innovative
pharmaceutical therapies to improve standards of care and address
diversified, unmet medical needs of people globally by leveraging
our world-class science and technology. With more than 125 years of
scientific expertise and a presence in more than 20 countries,
Daiichi Sankyo and its 18,000 employees around the world draw upon
a rich legacy of innovation and a robust pipeline of promising new
medicines to help people. In addition to a strong portfolio of
medicines for cardiovascular diseases, under the Group’s 2025
Vision to become a “Global Pharma Innovator with Competitive
Advantage in Oncology,” Daiichi Sankyo is primarily focused on
providing novel therapies in oncology, as well as other research
areas centered around rare diseases and immune disorders. Summary:
Responsibility for regulatory strategy to support the development
of biomarkers, companion diagnostic tests and other devices to
enhance the value of our oncology pharmaceutical products.
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 Qualifications: Successful candidates will be able to meet
the qualifications below with or without a reasonable
accommodation. Education Qualifications (from an accredited college
or university) Bachelor's Degree required Master's Degree preferred
Advanced degree in Pharm D, MD, PHD preferred Experience
Qualifications Experience Qualifications: 4 or More Years Solid
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 Travel: Ability to travel up to 10% 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.
Keywords: , East Brunswick , CDx Associate Director, Global Regulatory Affairs, Science, Research & Development , Basking Ridge, New Jersey
