aanchal shah
Senior Regulatory Health Consultant at Booz Allen Hamilton
senior regulatory health consultant booz allen hamilton
Booz Allen Hamilton
https://www.linkedin.com/company/booz-allen-hamilton
Maryland, United States
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Senior Regulatory Health Consultant
Booz Allen Hamilton
https://www.linkedin.com/company/booz-allen-hamilton
Supporting regulatory and clinical studies management activities for the Division of Applied Regulatory Science (DARS) at the Food and Drug Administration (FDA).
Maryland, United States
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Regulatory Health Consultant
Rare Genomics Institute
https://www.linkedin.com/company/rare-genomics-institute
Actively volunteering for the nonprofit organization ‘Rare Genomics Institute’. Developed a program called RareWear and currently support efforts to connect the rare disease community with wearable device companies. Conducted research on latest wearable medical device technologies that could be utilized to diagnose and manage rare genetic disorders. Established partnerships with various wearable companies and formed alliances with them to execute the program. In addition, designed the program operations to make the patient application process more efficient.
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Strategic Alliance Associate
Kaleido Biosciences
https://www.linkedin.com/company/kaleido-biosciences-inc.
Analyzed the regulatory approval pathway of a small molecule drug and developed a memorandum to facilitate its QIDP application to FDA. Evaluated various enrichment strategies to support pre-market clinical programs and expand target product profiles. Supported the company’s new drug development platform by identifying drug precedents and presenting case studies for extrapolation.
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Regulatory Affairs Project Intern
Kaleido Biosciences
https://www.linkedin.com/company/kaleido-biosciences-inc.
Gathered scientific evidence to support clinical safety, tolerance, utility and regulatory approvals for the company’s novel therapy candidates. Collaborated with the regulatory team to prepare clinical study protocols, Investigational New Drug (IND) application, and Generally Recognized As Safe (GRAS) determinations. Performed regulatory assessments on company safety documents. Reformed the company’s GRAS determination template to incorporate crucial safety and regulatory information and provided a single framework for conducting future GRAS analysis.
Lexington, MA
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Regulatory Affairs Co-op
Northeastern University Information Technology Services
https://www.linkedin.com/company/northeastern-university-information-technology-services
Worked part-time on campus as an ITS Service Desk Technician. Assisted customers with software issues and provided IT facilities solutions. Troubleshooted network printing systems and student computing.
Greater Boston Area
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Customer Experience Technician
Therapeutic Innovations, Inc.
https://www.linkedin.com/company/therapeutic-innovations-inc.
Participated in an Experiential Network Project with a medical device start-up and aided in constructing a regulatory strategy for the company’s respiratory device. Conducted a market analysis to identify the most suitable regulatory pathway for the respiratory device and advised on the regulations, guidelines and standards applicable to the device for marketing approval.
Greater Boston Area
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Experiential Network Project Intern
Lilu, Inc
https://www.linkedin.com/company/wearlilu
Contributed to developing a regulatory strategy to obtain a class I market recognition and a pre-market notification exemption from the FDA. Developed a labeling draft for the device in accordance with 21 CFR Part 801 and analyzed the company’s Good Manufacturing Practices (GMP) to ensure compliance with FDA’s General Controls provisions for medical devices.
Greater Boston Area
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Experiential Network Project Intern
Northeastern University
https://www.linkedin.com/company/northeastern-university
Governed Good Laboratory Practices and managed the Biotechnology Application Laboratory. Certified and trained in Biosafety Management, Chemical Hygiene and Regulated Medical Waste Shipping.
Greater Boston Area
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Graduate Teaching Assistant for Biotechnology Applications Laboratory
Nanavati Super Speciality Hospital
https://www.linkedin.com/company/nanavatimax-superspeciality-hospital
Worked in the departments of Microbiology, Hematology, Serology, Clinical pathology, Biochemistry, Blood banking and Histopathology.
Mumbai Area, India
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Intern
Master's degree
Regulatory Affairs in Drugs, Biologics and Medical Devices
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Northeastern University
https://www.linkedin.com/school/northeastern-university/
Master's degree
Biochemistry
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University of Mumbai
https://www.linkedin.com/school/university-of-mumbai/
Post graduate diploma
Dietetics and Clinical Nutrition Services
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University of Mumbai
https://www.linkedin.com/school/university-of-mumbai/
Bachelor's degree
Biochemistry
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University of Mumbai
https://www.linkedin.com/school/university-of-mumbai/
Advanced Regulatory Writing: Medical Devices
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Emerging Medical Device Markets
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FDA Pharmaceutical Regulations
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FDA and the eCTD
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Human Experimentation and Clinical Trials
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Medical Device Development
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Therapeutic Product development
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Pharmaceutical and Medical Device Law
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Strategic Planing and Project Management
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Anti-diabetic Property of Trigonellafoenum-graecum (fenugreek) and its Interaction with Anti-diabetic Drugs
Redevelopment Projects and their Implication in India
Health
National Service Scheme
https://www.linkedin.com/company/national-service-scheme
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Community Volunteer for Blood Donation Camps
Arts and Culture
Mithibai College of Arts Chauhan Institute of Science and A.J. College of Commerce and Economics
https://www.linkedin.com/company/mithibai
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Event Organizer for an Intercollegiate Academic festival "Luminescence"
Mithibai College of Arts Chauhan Institute of Science and A.J. College of Commerce and Economics
https://www.linkedin.com/company/mithibai
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Volunteer for an intercollegiate talent festival "KSHITIJ"
Northeastern University
www.youracclaim.com
Experiential Network
https://www.youracclaim.com/badges/52d76fb0-4379-4366-9c08-11def06ed128/linked_in_profile
Northeastern University
Biosafety Management
Northeastern University
Chemical Hygiene
Northeastern University
Regulatory Medical Waste Shipping
American Red Cross
FIRST AID/CPR/AED PROFESSIONAL RESCUER
ICAgile
ICAgile Certified Professional (ICP)
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I'm Russian. And I don't have words.I didn't choose this president. No one from my friends and family and everyone I know voted for him.People in…
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Booz Allen is honored to be one of Fortune magazine's World's Most Admired Companies.
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This post is specially for my international friends in the USA who are on F1 visa or an H1B struggling with the uncertainty of their visa status and…
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Ahmedabad
Aanchal Shah
Article Assistant at G.K. Choksi & Co.
https://ie.linkedin.com/in/aanchal-shah-a16a7bb2
Dublin 4
Aanchal Shah
Senior Business Analyst at HealthBeacon with 2.5 years of experience in the Digital Health Tech Space.
https://in.linkedin.com/in/aanchalatchicmomz
New Delhi
Aanchal Shah
Co-Founder @Chicmomz
https://www.linkedin.com/in/aanchalshah93
Seattle, WA
Aanchal Shah
Commerce Integrity at Meta
RA/QA/QC Referral Network
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https://www.linkedin.com/groups/3385585
Medical Device Opportunity
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https://www.linkedin.com/groups/131648
Regulatory Affairs Alumni Network - College of Professional Studies
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https://www.linkedin.com/groups/1856607
RADSP - Regulatory Affairs & Drug Safety Professionals
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https://www.linkedin.com/groups/128293
Regulatory Affairs, Drug Safety, Quality
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https://www.linkedin.com/groups/138119
Quality & Regulatory Network
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https://www.linkedin.com/groups/80327
🔥 MedicalDevicesGroup.net 🔥
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https://www.linkedin.com/groups/78665
Regulatory Affairs Jobs & Careers Forum
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https://www.linkedin.com/groups/1835637
Wearable / IoT
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https://www.linkedin.com/groups/1794802
Northeastern University College of Professional Studies
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https://www.linkedin.com/groups/2432047
Drug Regulatory Affairs
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https://www.linkedin.com/groups/989377
Regulatory Affairs Professionals Society (RAPS)
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https://www.linkedin.com/groups/110767
eCTD Regulatory Submissions Network
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https://www.linkedin.com/groups/1992398
TOPRA - The Organisation for Professionals in Regulatory Affairs
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https://www.linkedin.com/groups/1182787