David Tucker
Regulatory Affairs (RA) professional with more than 15 years experience in multiple dosage forms (so...
New York City Metropolitan Area, New York City Metropolitan Area, United States
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David Tucker’s Email david.t@intersectent.com
Social Media
David Tucker’s Location New York City Metropolitan Area, New York City Metropolitan Area, United States
David Tucker’s Current Industry Intersect
David Tucker’s Prior Industry Alvogen Pharma | Alfasigma Usa | Teva Pharmaceuticals | Endo Pharmaceuticals | Nycomed | Dupont Pharmaceuticals | Del Pharmaceuticals | Twin Laboratories
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Work Experience
Intersect
Regulatory Affairs Manager-CMC-Pharma
2021-11-01 00:00:00 - Present
Alvogen Pharma
Director, Regulatory Affairs
2020-06-01 00:00:00 - 2021-05-01 00:00:00
Alfasigma Usa
Director of Regulatory Affairs
2018-04-01 00:00:00 - 2020-06-01 00:00:00
Teva Pharmaceuticals
Associate Director / Manager, Regulatory Affairs
2011-10-01 00:00:00 - 2018-03-01 00:00:00
Endo Pharmaceuticals
Regulatory Affairs Manager / Senior Regulatory Affairs Associate
2008-07-01 00:00:00 - 2011-10-01 00:00:00
Nycomed
Regulatory Affairs Associate/Project Team Leader
2005-04-01 00:00:00 - 2008-07-01 00:00:00
Dupont Pharmaceuticals
Scientist/Lead Scientist
1998-11-01 00:00:00 - 2001-09-01 00:00:00
Del Pharmaceuticals
Analytical Chemist
1998-04-01 00:00:00 - 1998-11-01 00:00:00
Twin Laboratories
Chemist
1996-09-01 00:00:00 - 1998-03-01 00:00:00Skills
Languages
FAQ About David Tucker
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David Tucker is located at
New York City Metropolitan Area, New York City Metropolitan Area, United States -
David Tucker is a Regulatory Affairs (RA) professional with more than 15 years experience in multiple dosage forms (solid/liquid oral dosage, dermal, injectable, ophthalmic, etc.) and therapeutic areas in the pharmaceutical industry Analytical Chemist professional with 9 years’ experience in Method Development, Quality Assurance, and Quality Control development, testing and release of routine and experimental drug substance/products Specialized in RA strategy and execution for: • Early development projects (e.g. pre-exhibit batches) • Review, assessment and compilation of CMC/labeling documentation for regulatory submissions • Risk assessment of pre/post-submission submissions (IND, ANDA, NDA) • Involved in all areas of the relevant submission process including: -Review and critique of all incoming documentation for submission -Assurance that all submission documentation is “submission-ready” as per current FDA guidelines -Drafting of all submission summary sections -Processing appropriate documentation for submission -Strong chemical and biological science background to support regulatory strategy and submissions
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David Tucker currently works in the Intersect |
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No Languages Available
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David Tucker has prior
experience in the following industries:
Alvogen Pharma | Alfasigma Usa | Teva Pharmaceuticals | Endo Pharmaceuticals | Nycomed | Dupont Pharmaceuticals | Del Pharmaceuticals | Twin Laboratories -
David Tucker has the following professional experience:
Intersect | Alvogen Pharma | Alfasigma Usa | Teva Pharmaceuticals | Endo Pharmaceuticals | Nycomed | Dupont Pharmaceuticals | Del Pharmaceuticals | Twin Laboratories -
You can view David Tucker’s LinkedIn profile at LinkedIn URL
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David Tucker’s work email
addresses are
david.t@intersectent.com -
Intersect |
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