Dixa Patel Email and Phone Number
Dixa Patel work email
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Dixa Patel personal email
-Over 4 years of experience working in the field of Regulatory in the pharmaceutical /Biomedical and Life science sector.-Strong foundational knowledge in label control, regulatory compliance, CMC, Quality Assurance, and document management with a focus on quality and continuous improvement.-Deep understanding and ability to collaborate with R&D and Quality Assurance teams to resolve technical challenges in the product development of IND, NDA, BLA, ANDA, and 510(k) submissions.-Comprehensive knowledge of FDA, EMA, ICH guidelines related to CMC, GMP &GCP.-GCP training in accordance with ICH guidelines, gaining a comprehensive understanding of the responsibilities of the IRB/IEC, sponsor, and investigator.
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Irb SpecialistColumbia University Irving Medical CenterUnited States
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Regulatory Compliance AnalystLemed Specialty Pharmacy Jan 2022 - Present- Provided regulatory support to ensure compliance with federal and state guidelines, overseeing the development and implementation of compliance policies.-Collaborated with cross functional teams to optimize care within clinical setting,improving patient outcome. Developed expertise in insurance billing, audits, and regulatory compliance for organ Transplant, MI & cancer patient programs.
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Regulatory Affairs SpecialistFreyr Solutions Jul 2018 - Dec 2018Specialist • Prepared, reviewed, and submitted post-approval changes for Abbreviated New Drug Applications (ANDAs), ensuring compliance with regulatory requirements.• Led the preparation, review, and submission of lifecycle management documents including Annual Reports, Periodic Adverse Drug Experience Reports (PADERs), and labeling amendments for ANDAs.• Managed the preparation, review, and submission of lifecycle documents such as Protocols, CMC information, and amendments for IND applications.• Performing Multiple Quality control checks to ensure the high quality of the submission.
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Assistant Pharmacy PractitionerUnited Care Pharmacy Feb 2017 - Oct 2017
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Quality Assurance /Labeling SpecialistPenta Pharmaceuticals Jan 2015 - Jun 2015- Performed In Process Checks during manufacturing & packging activities. -Provided Line Clearance in manufacturing, Packaging and Warehouse.-Sampaling of Products in Manufacturing and Packing.-Issuance of Documents to other departments.-Calibration of Instruments, Equipments.etc-Ensured Online documentation and compliance throught the plant. - Review and approved standard operating procedure, Change controls and Deviations. - Performed Equipment Qualification and Validation & QMS related Activities
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TutorVariant Academy Feb 2012 - Dec 2014Assisted students in one to one classes of biology , mathematics, chemistry and statistics. Helping them in problem solving strategies and guidance for the academic education.
Dixa Patel Skills
Dixa Patel Education Details
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Long Island UniversityDrug And Regulatory Affairs -
Uka Tarsadia UniversityPharmacy
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Udemy & CourseraCertifications
Frequently Asked Questions about Dixa Patel
What company does Dixa Patel work for?
Dixa Patel works for Columbia University Irving Medical Center
What is Dixa Patel's role at the current company?
Dixa Patel's current role is IRB specialist.
What is Dixa Patel's email address?
Dixa Patel's email address is di****@****drx.com
What schools did Dixa Patel attend?
Dixa Patel attended Long Island University, Uka Tarsadia University, Udemy & Coursera.
What skills is Dixa Patel known for?
Dixa Patel has skills like Leadership, Pharmaceutical Industry, Research, Management, Regulatory Affairs, Project Management.
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