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Dj Chatterjee, Ph.D. is listed as Senior Global Regulatory Affairs Professional based in Princeton, New Jersey, United States. AeroLeads shows a work email signal at novonordisk-us.com and a matched LinkedIn profile for Dj Chatterjee, Ph.D..
Dj Chatterjee, Ph.D. previously worked as Sr. Director, Global Regulatory Affairs at Otsuka Pharmaceutical Development & Commercialization, Inc. and Director, Regulatory Affairs at Sanofi. Dj Chatterjee, Ph.D. holds Bachelor Of Pharmacy (Hons) from Jadavpur University.
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My passion is science and I offer a unique combination of exceptional technical knowledge and business competencies accumulated from over 25 years of experience in several roles such as a Federal Regulator (FDA), Corporate Regulatory Affairs Professional and a Clinical Pharmacology Professional. I have a wide breadth of expertise in managing global clinical trials and regulatory submissions towards marketing authorizations of new drugs, conducting research to direct regulatory strategy, and working collaboratively with major pharmaceutical organizations, contract research organizations (CRO’s), the FDA, and global health authorities.As a scientific leader, I am adept at providing project specific regulatory guidance, mentorship, training, and direction to global clinical and regulatory professionals, I have demonstrated success in supervising clinical and regulatory activities towards achieving marketability of new drugs.My goal is to bring my strong capabilities in coordinating, organizing, and managing complex clinical and regulatory functions/activities with global project teams towards optimizing novel drug development strategies within the Pharmaceutical and Biotechnology industry.Specialties: Regulatory affairs, Clinical Pharmacology, FDA/EMA and Global Health Authorities, IND/NDA/BLA/MAA filing and regulatory review, regulatory negotiation strategies, Strategic Planning, Execution/Integration, Regulatory Science and Research, Regulatory Policy and Guidance, Clinical Pharmacology research, Translational research.
Listed skills include Pharmacology, Drug Development, Regulatory Affairs, Clinical Development, and 11 others.
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Responsible for all global regulatory strategy, management and execution of drug development projects towards the availability/marketability of quality new medicines to patients globally.
Paris, France, Fr
Responsible for providing US regulatory leadership, strategy, submissions oversight and maintenance for key new drug development projects (multiple assets within Phases 1, 2 ,3 of development), marketed and lifecycle expansion projects within the Immunology and Inflammation (including for the treatment of COVID-19 infection in hospitalized patients), and Neurology.
Leverkusen, North Rhine-Westphalia, De
Responsible for global regulatory strategy, submissions and compliance involved with new drug development of projects within Bayer's general medicine franchise
Bagsværd, Dk
Manage regulatory clinical issues/strategies throughout all phases of new drug development and coordinate all submissions to US (FDA) and EU regulatory/health authorities
Bagsværd, Dk
Designed clinical/pharmacology programs and research studies for drug development and FDA submission of new drugs (small molecules and biologics) for global marketing authorization.
Silver Spring, Md, Us
Reviewed all clinical pharmacology related matters on IND and NDA submissions to the FDA for US marketing authorizations of new drugs from pharmaceutical companies around the world
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Dj Chatterjee, Ph.D. is listed as Senior Global Regulatory Affairs Professional.
AeroLeads has found 1 work email signal at @novonordisk-us.com for Dj Chatterjee, Ph.D..
Dj Chatterjee, Ph.D. is based in Princeton, New Jersey, United States.
Dj Chatterjee, Ph.D. has worked for Otsuka Pharmaceutical Development & Commercialization, Inc., Sanofi, Bayer Healthcare, Novo Nordisk A/S, and Fda (Cder).
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Dj Chatterjee, Ph.D. holds Bachelor Of Pharmacy (Hons) from Jadavpur University.
Dj Chatterjee, Ph.D. is listed with skills including Pharmacology, Drug Development, Regulatory Affairs, Clinical Development, Fda, Pharmaceutical Industry, Clinical Pharmacology, and Clinical Research.
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