Akanksha Kulshreshtha
Manager, Regulatory Affairs at Fujifilm Sonosite
- Role
- Regulatory Affairs Manager at FUJIFILM Sonosite, Inc.
- Location
- Seattle, WA, US
- LinkedIn followers
- 500 followers
About Akanksha Kulshreshtha
To work in a challenging and intellectually stimulating environment that offers avenues for growth based on capabilities and hard work and to embark an innovative and challenging career in the field of Regulatory Affairs and Clinical Research.STATEMENT OF QUALIFICATION:•Sound knowledge in the area of Regulatory Affairs and well versed with the regulatory framework for Drugs, Medical Devices, and Biologicals.• Research experience in neurodegenerative disorders and anti-inflammatory and analgesic drugs.• Professional experience in Regulatory Affairs, Quality Assurance, and Quality Control• Avid learner, attention for details, good organization and planning skills, adaptable, team-worker, dependable. Strong technical writing, communication, interpersonal, and presentation skills.Skills:Technical skills: Regulatory Compliance, Clinical trials, Clinical research, FDA regulations and 21 CFRs, Good Manufacturing Practice (GMPs), Good Clinical Practices (GCP), Regulatory Strategy Preparation, Drugs,biologicals and device pathways to the market (IND, NDA, ANDA, BLA, 510 (k), PMA, De novo), ISO 13485 (Quality Management System), ISO 14971 (Application of Risk Management to Medical Devices), ICH guidelines, Human subject protection regulations, IRB, HIPAA, technical writing skills, document management, complaint management Software Skills: MS office (MS word, PowerPoint, excel, outlook, publisher) Adobe Acrobat, SAS JMP, SAP, Vizio, LIMS, Schrodinger, VLife MDS, AutoDock and Modeller, Graph Pad PrismSocial Skills: Attention to details, Organized, Focussed, Creative, Strong-willed, determined, teamwork, multitask, excellent verbal and written communication skills
Experience
Regulatory Affairs Manager
Oct 2024 — Present
Education
Guru Gobind Singh Indraprastha University
Bachelor of Pharmacy (B.Pharm.), Pharmaceutical Sciences
2005 — 2009
Indian Institute of Technology (Banaras Hindu University), Varanasi
Master of Pharmacy, Medicinal and Pharmaceutical Chemistry
2009 — 2011
Panjab University
Doctor of Philosophy - PhD, Pharmaceutical Sciences
2013 — 2018
University of Washington
Master of Science - MS, Regulatory Affairs
2018 — 2020
Skills
- Quality Control
- V&V
- Pharmaceutical Research
- Medicinal Chemistry
- Uv/Vis
- Formulation
- Hplc
- Technology Transfer
- Chromatography
- Anda
- Pharmacokinetics
- Pharmaceutics
- Drug Discovery
- Research, Chemical Synthesis, Analysis
- Organic Chemistry
- Pharmacology
- Lc-Ms
- Life Sciences
- Regulatory Affairs
- Lifesciences
- Pharmaceutical Industry
- Sop
- Analytical Chemistry
- Drug Delivery
- Generic Programming
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