Aakanksha (AK) Khushu
Regulatory Affairs Analyst at USDM Life Sciences
MSPM with specialization in Regulatory Affairs for Drugs, Biologics and Medical Devices
A graduate student majoring in Project Management with concentration in Regulatory Affairs in Drugs, Biologics and Medical Devices. Experienced in processing and performing quality checks on Individual Case Safety Reports (ICSRs) for post-marking, spontaneous and clinical trial cases on ARGUS Safety Database and iMedidata.

Thorough knowledge of FDA guidelines for drug (IND/NDA) and medical device clearance/approvals (510(k)/ PMA), ICH guidelines, Quality Management System (ISO 13485/ 21 CFR Part 820), GMP, GLP, GCP, IRB, Recalls, Labeling, Packaging, Marketing requirements, and Pharmacovigilance.
USDM Life Sciences
https://www.linkedin.com/company/usdm
Regulatory Affairs Analyst
United States
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Otomagnetics, Inc
https://www.linkedin.com/company/otomagnetics
Quality and Regulatory Intern
•Researched and documented all the sections (CMC, Pre-clinical summary) in a Pre-IND meeting package
•Coordinated the Pre-IND FDA correspondence and maintained documentation
•Managed 7+ vendors and led negotiations
•Partnered with 2 new advisors by arranging meetings and facilitated negotiations
•Coordinated with the VP-R&D to create a project plan as well as managed the budget and schedule for 4 in-house projects related to hearing loss induced by chemotherapy in children and infants
•Managed the procurement and purchasing of laboratory and project specific requirements
Gaithersburg, Maryland, United States
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Cognizant
https://www.linkedin.com/company/cognizant
Drug Safety Associate
•Processed Individual Case Safety Reports using ARGUS safety database related to oncology-related clinical trial, post-marketing, and spontaneous case
•Performed triage, data entry, and quality checks for 800+ patient cases to ensure accuracy of data submitted to the FDA
•Received early promotion to Quality Control based on accuracy and timeliness of case processing
Mumbai Area, India
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Cipla
https://www.linkedin.com/company/cipla
Research And Development-Intern
•Performed quality control tests like High- Performance Liquid Chromatographic studies (HPLC), dissolution studies, UV ray studies for Anti-HIV drugs
•Assisted an internal audit of quality control studies to ensure gaps were recognized and remediated
•Managed to view and understand the process of tablet manufacturing and labelling
Mumbai, Maharashtra, India
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Project Management
Master's
Northeastern University
https://www.linkedin.com/school/northeastern-university/
Regulatory Affairs in Drugs, Biologic and Medical Devices
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Pharmacy
Bachelor's degree
All India Shivaji Memorial Societys College of Pharmacy, Pune
https://www.linkedin.com/school/all-india-shivaji-memorial-societys-college-of-pharmacy-pune/
Optimization studies for a herbal cream containing Sesame Oil.
•Applied optimization techniques to leverage Sesame oil as a natural anti-wrinkle ingredient
•Utilized Brookfield Viscometer to determine spreadability of the cream
QSAR studies for some diarylnicotiamide derivatives as NNRTI’s.
•Used VLife software to make structures of the diarylnicotinamide pharmacophore to study substitutes in drug structure
•Performed molecular docking for 21 derivates of diarylnicotinamide to confirm efficacy of the molecule
•Studied 3D QSAR model of the anti-HIV drug molecules to obtain a higher potency compound of diarylnicotinamide pharmacophore
Social Services
AISSMS Pharma Graduates Association
Treasurer
Education
Indian Pharmaceutical Association - Students Forum Pune
https://www.linkedin.com/company/ipasf-pune
Coordinator
https://aissmscop.com/wp-content/uploads/2018/03/NPW-report.pdf
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Health
APGA
Member
Animal Welfare
Bhumi
https://www.linkedin.com/company/bhumiorg
Volunteer
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https://www.linkedin.com/learning/project-management-foundations-4
Project Management Foundations
www.linkedin.com
LinkedIn
http://www.linkedin.com/learning/project-management-healthcare-projects
Project Management: Healthcare Projects
www.linkedin.com
LinkedIn
http://www.linkedin.com/learning/project-management-preventing-scope-creep-2
Project Management: Preventing Scope Creep
www.linkedin.com
LinkedIn
http://www.linkedin.com/learning/project-management-foundations-requirements
Project Management Foundations: Requirements
www.linkedin.com
LinkedIn
https://myhbp.org/hmm12/export/completion-certificate/project_management.pdf
Harvard Manager Mentor in Project Management
myhbp.org
Harvard Business Publishing
Registered Pharmacist
Maharashtra State Pharmacy Council - India
https://in.linkedin.com/in/sujit-salunke-ab4a3819b
Sujit Salunke
M.S. (Pharm.) Medicinal Chemistry
Yeola
https://www.linkedin.com/in/mbartholomew
Michael Bartholomew
Executive, Board of Director, Founder and Serial Entrepreneur
San Francisco Bay Area
https://www.linkedin.com/in/ketan-gujarathi-3745ba22
Ketan Gujarathi
General Manager, Biologics Drugs Substance Operations at Bristol Myers Squibb
East Syracuse, NY
https://in.linkedin.com/in/ashuta-parab
Ashuta Parab
Former Global Clinical Supply Intern at Novartis I MBA (Pharmaceutical Management), NIPER-Hyderabad |
Mumbai
https://in.linkedin.com/in/surekha-perumalla-04678220b
surekha perumalla
B.pharm fresher. Actively looking for pharmacovigilance, clinical data management , clinical research , pharmaceutical industries domains.
Hyderabad
https://in.linkedin.com/in/snehal-dhobale-7b874a116
SNEHAL DHOBALE
Business Analyst - Product Management Regulatory at Aris Global
Pune
https://in.linkedin.com/in/pooja-takudage-0003b264
Pooja Takudage
Assistant Manager-Medical Content Services at MEDICCA PRESS Limited
Pune
https://www.linkedin.com/in/medhajosh
Medha Joshi
Associate Professor (Tenured), Department of Pharmaceutical Sciences at Midwestern University (AZ)
Glendale, AZ
https://in.linkedin.com/in/roshani-pardeshi-8435b2197
ROSHANI PARDESHI
M.Pharmacy (Quality Assurance )
Pune
https://in.linkedin.com/in/shruti-rudraksha-6177ba173
Shruti Rudraksha
M Pharm (Clinical Pharmacy)
Maharashtra, India
https://in.linkedin.com/in/harshita-raj-2b7553204
Harshita Raj
Bachelor of Pharmacy !! Gujrat Technology University!!
Ahmedabad
https://in.linkedin.com/in/revati-nakate-6b4439204
Revati Nakate
Immediate joiner, 3+ years of experience, Interested in Pharmacovigilance Quality Assurance
Pune
https://in.linkedin.com/in/shivkumar-bhusse-ba7596102
Shivkumar bhusse
Trainee junior data analyst at Cognizant
Pune
https://in.linkedin.com/in/kaustubh-kasture-38218a219
Kaustubh Kasture
Student at SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Nashik
https://in.linkedin.com/in/yogesh-rewachandani-6ba332129
Yogesh Rewachandani
Executive at MEYER ORGANICS PVT. LTD.
Goa, India
https://www.linkedin.com/in/gandharvkapoor
Gandharv Kapoor
MTS VMware | MS CS SBU | IIIT Delhi
San Francisco Bay Area
https://in.linkedin.com/in/krutika-redekar-aa43931b4
krutika redekar
Attended Shivaji University, Kolhapur
Pune
https://in.linkedin.com/in/prince-minocha-974350161
Prince Minocha
Digital Marketer
Delhi, India
https://ae.linkedin.com/in/sharan-wadhwani
Sharan Wadhwani
Financial Analyst at Nottingham Economics & Finance Society
United Arab Emirates
Hossein Mostafavi , PhD
      
          



            
              
        
              
  

    
        I have known Aakansha since she joined our company as an intern and soon she became one of our key employees to prepare and file pre IND packages to the FDA. She is so smart and learned our process so quickly and then applied it in her daily responsibilities with full details. She is so organized, an excellent team player. 
Overall it is a very easy and pleasant experience to work with her. 
As Women’s History Month continues, we would like to appreciate the hard work that women do all around the world. Today, we would like to highlight…
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I vividly remember the first two years I moved from my home country.Every Monday morning it felt like I had to restructure my 🧠 so it specifically…
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🇺🇦 Wrapped up another great class in Dodge Hall at Northeastern University this evening! So thankful for the opportunity to teach for such a great…
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Pharmaceutical, Biotech, Medical & Healthcare Network: Business, Jobs, Events & News
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Northeastern University College of Professional Studies
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