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Junaid Ur Rahman Mohammed is listed as Actively looking for full- time opportunities l MS in Regulatory Affairs at Northeastern University at Incyte, a company with 1767 employees, based in Boston, Massachusetts, United States. AeroLeads shows a matched LinkedIn profile for Junaid Ur Rahman Mohammed.
Junaid Ur Rahman Mohammed previously worked as Global Clinical Manufacturing QA GMP at Incyte and Regulatory Affairs Intern - Capstone Project at Microbiome Insights Inc.. Junaid Ur Rahman Mohammed holds Master Of Science - Ms, Regulatory Affairs, 3.97 from Northeastern University.
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A graduate student from Northeastern University's Master of Science in Regulatory Affairs program, seeking challenging roles in a biotechnology/pharmaceutical/ medicinal device company. Worked with a better understanding of Investigational New Drug (IND), New Drug Application (NDA), ANDA, 510k with eCTD preparation, regulatory labeling, annual reports, and package inserts. A greater understanding of GCP and GMP guidelines. Trained in preparing informed consent forms (ICF), and data safety update reports (DSUR), and have insight knowledge in investigators' brochures, protocols, and clinical trial applications. Effectively work in both independent and collaborative environments. Willing to relocate to any location in the USA.SKILLS: Regulatory: eCTD (ICH M4), IND, NDA, ANDA, 510K, De Novo, Warning letters, recalls, DSUR, BLA, PMA, CAPA, HUD, and HDE. 21 CFR 11, 50, 54, 201.56, 201.66, 300, 600, 820, FDA, EMA, and ICH guidelines, GCP (ICH E6), CGMP (ICH Q7/CFR 210) Clinical: Informed Consent Form (ICF), Clinical Protocol, Investigator brochures (IB), Institutional Review Boards (IRB)Database: drugs@fda, drugbank, PubMed, NCBI, dailymed, clinicaltrials.gov Technical: MS PowerPoint, MS Excel, MS Word, Outlook, Adobe Acrobat, SharePoint
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Wilmington, Delaware, United States
Provide QA leadership and oversight for small molecule product management. Implement, perform, and maintain Quality Systems and procedures, contributing to continuous improvement. Support the implementation and promotion of Incyte Quality Management Systems and Global Policies. Develop, implement, and maintain Incyte procedures for global clinical.
Preparing regulatory requirements for the safety and manufacturing of microbiomes products in the United StatesBuilding a risk-benefit profile and preparing timelines for regulatory submission of microbiomes to FDACreating an outline for microbiomes product development and regulatory pathway for its review and FDA approval
Boston, Massachusetts, United States
Conducted COVID-19 tests as per the clinical protocol and maintained the safety of biomedical samplesMaintained clean and efficient clinical flow by regulating medical waste disposal
Boston, Massachusetts, United States
Collecting informed consent forms from university students, professors, and staff arriving for the COVID 19 test and aiding with system troubleshooting as needed.Maintained specimen sample data input in the Broad and LSTC databases, as well as patient data privacy in the COVID 19 testing procedure.Aiding with the distribution of Covid 19 vaccinations and.
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Conducted research on COVID-19 hotspots and identified target audience for Negative Pressure SteriDome (NPS), an FDA approved biocontainment solutionDesigned marketing and regulatory strategy for the device utilizing situational, competitive, and SWOT analysisEnhanced the branding by integrating written testimonials and a one-pager about medical device.
Hyderabad, Telangana, India
Performed observational studies on patients for risk factors associated with hypertension in Diabetes Mellitus. Reviewed Study protocol, patient information Sheet, informed consent form, product information, and case report form.
Hyderabad, Telangana, India
Received training in various departments such as solid oral dosage form with tablet press and manual capsule filling machine, liquid oral dosage formulation, manufacturing, and quality control.
Other employees you can reach at incyte.com. View company contacts for 1767 employees →
Vincent Cochemé
Colleague at Incyte
Renens, Vaud, Switzerland, Switzerland
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KT
Kelly Traikovich
Colleague at Incyte
Duluth, Georgia, United States, United States
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LB
Lakshmi Balasubramaniam
Colleague at Incyte
Basking Ridge, New Jersey, United States, United States
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JP
Julie Pochelu
Colleague at Incyte
Morges, Vaud, Switzerland, Switzerland
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RH
Rodrigo Hess Michelini
Colleague at Incyte
Philadelphia, Pennsylvania, United States, United States
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WS
Wen Shi
Colleague at Incyte
Berwyn, Pennsylvania, United States, United States
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CM
Christopher Maddage
Colleague at Incyte
United States, United States
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JB
John Barbaro
Colleague at Incyte
Lancaster, Pennsylvania, United States, United States
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GM
Gina Mcneil
Colleague at Incyte
United States, United States
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ML
Mark Lapilusa
Colleague at Incyte
Harrington Park, New Jersey, United States, United States
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Relevant Coursework: Global Impact of eCTD, Introduction to Food and Drug Administration (FDA), Strategic Planning and Project Management.
Relevant Coursework: Pharmaceutical Regulations, Pharmaceutics, Pharmaceutical Analysis, Clinical and Hospital Pharmacy, Physical Pharmacy.
Quick answers generated from the profile data available on this page.
Junaid Ur Rahman Mohammed works for Incyte.
Junaid Ur Rahman Mohammed is listed as Actively looking for full- time opportunities l MS in Regulatory Affairs at Northeastern University at Incyte.
Junaid Ur Rahman Mohammed is based in Boston, Massachusetts, United States while working with Incyte.
Junaid Ur Rahman Mohammed has worked for Incyte, Microbiome Insights Inc., Northeastern University, Residential Security Office At Northeastern University, and Breegi Scientific, Inc..
Junaid Ur Rahman Mohammed's colleagues at Incyte include Vincent Cochemé, Kelly Traikovich, Lakshmi Balasubramaniam, Julie Pochelu, and Rodrigo Hess Michelini.
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Junaid Ur Rahman Mohammed holds Master Of Science - Ms, Regulatory Affairs, 3.97 from Northeastern University.
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