Daiichi Sankyo US
CDx Associate Director, Global Regulatory Affairs
Daiichi Sankyo US, Basking Ridge, New Jersey, us, 07920
CDx Associate Director, Global Regulatory Affairs
Join to apply for the
CDx Associate Director, Global Regulatory Affairs
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Daiichi Sankyo US CDx Associate Director, Global Regulatory Affairs
2 weeks ago Be among the first 25 applicants Join to apply for the
CDx Associate Director, Global Regulatory Affairs
role at
Daiichi Sankyo US 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. Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Daiichi Sankyo US by 2x Get notified about new Director Global Regulatory Affairs jobs in
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Join to apply for the
CDx Associate Director, Global Regulatory Affairs
role at
Daiichi Sankyo US CDx Associate Director, Global Regulatory Affairs
2 weeks ago Be among the first 25 applicants Join to apply for the
CDx Associate Director, Global Regulatory Affairs
role at
Daiichi Sankyo US 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. Seniority level
Seniority level Not Applicable Employment type
Employment type Full-time Job function
Job function Legal Industries Biotechnology Research, Hospitals and Health Care, and Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Daiichi Sankyo US by 2x Get notified about new Director Global Regulatory Affairs jobs in
Basking Ridge, NJ . East Brunswick, NJ $160,000.00-$200,000.00 3 weeks ago Whippany, NJ $169,865.00-$254,798.00 5 days ago Director, Global Regulatory Affairs – Global Labeling Strategy
Morristown, NJ $172,500.00-$249,166.66 6 days ago Bridgewater, NJ $176,000.00-$243,000.00 5 days ago Executive Director, Regulatory Affairs Strategist
Piscataway, NJ $170,000.00-$200,000.00 1 week ago Associate Director, Global Regulatory Affairs – Global Labeling Strategy
Morristown, NJ $147,000.00-$212,333.33 6 days ago Global Regulatory Affairs Device Head, Specialty Care Device and Combination Products (Sr. Director)
Morristown, NJ $202,500.00-$292,500.00 1 week ago Newark, NJ $270,000.00-$340,000.00 15 hours ago Director, Regulatory Affairs (Global Labeling)
Bridgewater, NJ $176,000.00-$243,000.00 19 hours ago Senior Director, Regulatory Affairs -Specialty
Director, Global Regulatory Affairs (Business Integration Lead)
Raritan, NJ $160,000.00-$276,000.00 6 days ago Director, Regulatory Affairs Global Labeling
Parsippany, NJ $210,375.00-$272,250.00 3 weeks ago Executive Director, Regulatory Affairs Strategist
Bridgewater, NJ $247,000.00-$345,467.00 4 days ago Raritan, NJ $168,000.00-$271,400.00 2 weeks ago CDx Associate Director, Global Regulatory Affairs
Executive Director, Global Medical Affairs
Director, WW Medical Neuroscience, Neuropsychiatry
Raritan, NJ $194,000.00-$334,650.00 2 days ago Distinguished Scientist, Clinical Research, Upper GI
Rahway, NJ $304,800.00-$479,800.00 1 day ago (Senior) Manager, Market Access and Reimbursement, AWC - Remote
We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr