Associate Director Regulatory Affairs
1 month ago
Join a Legacy of Innovation 110 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 100 years of scientific expertise and a presence in more than 20 countries, Daiichi Sankyo and its 16,000 employees around the world draw upon a rich legacy of innovation and a robust pipeline of promising new medicines to help people. 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
The Associate Director, Regulatory Affairs – Regulatory Project Management (RPM) provides planning and drives coordination of global and US regulatory activities. The Associate Director RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global regulatory team (GRT) for assigned projects and activities to achieve regulatory milestones and deliverables successfully and in a timely manner. The Associate Director, RPM is considered an expert for all RPM activities and processes and is responsible for independently leading regulatory project management activities without additional guidance. The Associate Director, RPM provides impactful contributions to the RPM group and the regulatory affairs organization by identifying gaps in RPM processes and suggesting and integrating operational and procedural excellence best practice into RPM processes to enhance regulatory affairs capabilities.
Responsibilities
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Director, Global Regulatory Affairs
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Associate Director, US Regulatory Affairs Strategy
2 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Associate Director, Regulatory Operations
2 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Director, US Regulatory Affairs Strategy
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Director, State Government Affairs
2 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Director, Global Medical Affairs Oncology
3 weeks ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Associate Director, Informatics
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Associate Director, External Sponsored Research
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 120 years of scientific expertise and a presence...
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Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 120 years of scientific expertise and a presence...
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Associate Director, Clinical Pharmacology
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingCompany is committed to diversity and inclusion. We are an equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical Pharmacology and Modeling & Simulation plans from FIH to post registration....
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Director, Labeling
2 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Associate Director, Companion Diagnostics Lead
1 month ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Associate Director, Medical Intelligence
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Director, Informatics
3 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Director, Medical Content
2 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...
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Director, Public Policy
2 months ago
Basking Ridge, New Jersey, United States Daiichi Sankyo Full timeJoin a Legacy of Innovation 110 Years and CountingDaiichi 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 100 years of scientific expertise and a presence...