aakanksha ( ak ) khushu
Regulatory Affairs Analyst at USDM Life Sciences
mspm specialization regulatory affair drug , biologics medical device
graduate student majoring project management concentration regulatory affair drug , biologics medical device . experienced processing performing quality check individual case safety report ( icsrs ) post-marking , spontaneous clinical trial case argus safety database imedidata . thorough knowledge fda guideline drug ( ind/nda ) medical device clearance/approvals ( 510 ( k ) / pma ) , ich guideline , quality management system ( iso 13485/ 21 cfr part 820 ) , gmp , glp , gcp , irb , recall , labeling , packaging , marketing requirement , pharmacovigilance .
USDM Life Sciences
https://www.linkedin.com/company/usdm
United States
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Regulatory Affairs Analyst
Otomagnetics, Inc
https://www.linkedin.com/company/otomagnetics
•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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Quality and Regulatory Intern
Cognizant
https://www.linkedin.com/company/cognizant
•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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Drug Safety Associate
Cipla
https://www.linkedin.com/company/cipla
•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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Research And Development-Intern
Master's
Regulatory Affairs in Drugs, Biologic and Medical Devices
Project Management
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Northeastern University
https://www.linkedin.com/school/northeastern-university/
Bachelor's degree
Pharmacy
All India Shivaji Memorial Societys College of Pharmacy, Pune
https://www.linkedin.com/school/all-india-shivaji-memorial-societys-college-of-pharmacy-pune/
•Applied optimization techniques to leverage Sesame oil as a natural anti-wrinkle ingredient
•Utilized Brookfield Viscometer to determine spreadability of the cream
Optimization studies for a herbal cream containing Sesame Oil.
•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
QSAR studies for some diarylnicotiamide derivatives as NNRTI’s.
Social Services
AISSMS Pharma Graduates Association
Treasurer
Education
Indian Pharmaceutical Association - Students Forum Pune
https://www.linkedin.com/company/ipasf-pune
https://aissmscop.com/wp-content/uploads/2018/03/NPW-report.pdf
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Coordinator
Health
APGA
Member
Animal Welfare
Bhumi
https://www.linkedin.com/company/bhumiorg
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Volunteer
LinkedIn
www.linkedin.com
Project Management Foundations
https://www.linkedin.com/learning/project-management-foundations-4
LinkedIn
www.linkedin.com
Project Management: Healthcare Projects
http://www.linkedin.com/learning/project-management-healthcare-projects
LinkedIn
www.linkedin.com
Project Management: Preventing Scope Creep
http://www.linkedin.com/learning/project-management-preventing-scope-creep-2
LinkedIn
www.linkedin.com
Project Management Foundations: Requirements
http://www.linkedin.com/learning/project-management-foundations-requirements
Harvard Business Publishing
myhbp.org
Harvard Manager Mentor in Project Management
https://myhbp.org/hmm12/export/completion-certificate/project_management.pdf
Maharashtra State Pharmacy Council - India
Registered Pharmacist
https://in.linkedin.com/in/sujit-salunke-ab4a3819b
Yeola
Sujit Salunke
M.S. (Pharm.) Medicinal Chemistry
https://www.linkedin.com/in/mbartholomew
San Francisco Bay Area
Michael Bartholomew
Executive, Board of Director, Founder and Serial Entrepreneur
https://www.linkedin.com/in/ketan-gujarathi-3745ba22
East Syracuse, NY
Ketan Gujarathi
General Manager, Biologics Drugs Substance Operations at Bristol Myers Squibb
https://in.linkedin.com/in/ashuta-parab
Mumbai
Ashuta Parab
Former Global Clinical Supply Intern at Novartis I MBA (Pharmaceutical Management), NIPER-Hyderabad |
https://in.linkedin.com/in/surekha-perumalla-04678220b
Hyderabad
surekha perumalla
B.pharm fresher. Actively looking for pharmacovigilance, clinical data management , clinical research , pharmaceutical industries domains.
https://in.linkedin.com/in/snehal-dhobale-7b874a116
Pune
SNEHAL DHOBALE
Business Analyst - Product Management Regulatory at Aris Global
https://in.linkedin.com/in/pooja-takudage-0003b264
Pune
Pooja Takudage
Assistant Manager-Medical Content Services at MEDICCA PRESS Limited
https://www.linkedin.com/in/medhajosh
Glendale, AZ
Medha Joshi
Associate Professor (Tenured), Department of Pharmaceutical Sciences at Midwestern University (AZ)
https://in.linkedin.com/in/roshani-pardeshi-8435b2197
Pune
ROSHANI PARDESHI
M.Pharmacy (Quality Assurance )
https://in.linkedin.com/in/shruti-rudraksha-6177ba173
Maharashtra, India
Shruti Rudraksha
M Pharm (Clinical Pharmacy)
https://in.linkedin.com/in/harshita-raj-2b7553204
Ahmedabad
Harshita Raj
Bachelor of Pharmacy !! Gujrat Technology University!!
https://in.linkedin.com/in/revati-nakate-6b4439204
Pune
Revati Nakate
Immediate joiner, 3+ years of experience, Interested in Pharmacovigilance Quality Assurance
https://in.linkedin.com/in/shivkumar-bhusse-ba7596102
Pune
Shivkumar bhusse
Trainee junior data analyst at Cognizant
https://in.linkedin.com/in/kaustubh-kasture-38218a219
Nashik
Kaustubh Kasture
Student at SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
https://in.linkedin.com/in/yogesh-rewachandani-6ba332129
Goa, India
Yogesh Rewachandani
Executive at MEYER ORGANICS PVT. LTD.
https://www.linkedin.com/in/gandharvkapoor
San Francisco Bay Area
Gandharv Kapoor
MTS VMware | MS CS SBU | IIIT Delhi
https://in.linkedin.com/in/krutika-redekar-aa43931b4
Pune
krutika redekar
Attended Shivaji University, Kolhapur
https://in.linkedin.com/in/prince-minocha-974350161
Delhi, India
Prince Minocha
Digital Marketer
https://ae.linkedin.com/in/sharan-wadhwani
United Arab Emirates
Sharan Wadhwani
Financial Analyst at Nottingham Economics & Finance Society
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. 
Liked by Aakanksha (AK) Khushu
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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…
Liked by Aakanksha (AK) Khushu
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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…
Liked by Aakanksha (AK) Khushu
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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…
Pharmaceutical, Biotech, Medical & Healthcare Network: Business, Jobs, Events & News
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Northeastern University College of Professional Studies
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