Master of Science (MS) (Regulatory Affairs for Drugs, Medical Devices and Biologics)
2013-2015
Rajiv Gandhi University of Health Sciences
Bachelor's degree (Pharmacy)
2008-2012
Asha Mathew Skills
Regulatory Compliance
Cosmetics
FDA and EU Regulations
Clinical Trials
MedWatch
Market Research
Regulatory Documentation Processes
Quality System Regulations
Pre Market Approval (PMA) Application
Combination Products
Investigational New Drug Application (IND)
Clinical Research
GLP
Orphan Drugs
GCP
New Drug Application (NDA)
Human Subject Experimentation
510K Submissions
eCTD
Data Analysis
Investigational Device Exemption (IDE)
New Drug, Medical Device and Biologics Development
Abbreviated New Drug Application (ANDA)
Healthcare
GMP
Research
Good verbal and written Communication
Comprehensive problem solving abilities
Microsoft Office
PowerPoint
Microsoft Excel
Medical Devices
IND
Regulatory Affairs
Microsoft Word
SOP
Pharmaceutical Industry
OTC Regulations
Electronic Common Technical Document (eCTD)
Good Clinical Practice (GCP)
Standard Operating Procedure (SOP)
Asha Mathew Summary
Asha Mathew, based in White Plains, NY, US, is currently a Regulatory Affairs Manager Wellness at Haleon. Asha Mathew brings experience from previous roles at Alchemee (formerly The Proactiv Company), Haleon and Premier Brands of America Inc.. Asha Mathew holds a 2013 - 2015 Master of Science (MS) in Regulatory Affairs for Drugs, Medical Devices and Biologics @ Northeastern University. With a robust skill set that includes Regulatory Compliance, Cosmetics, FDA and EU Regulations, Clinical Trials, MedWatch and more. Asha Mathew has 2 emails on RocketReach.
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