Mohit Kashyap
Senior Director Regulatory Affairs @Dunn Regulatory Associates, Llc
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WORK HISTORY
Senior Director Regulatory Affairs @Dunn Regulatory Associates, Llc
Washington, DC, US
EDUCATION
University of Wisconsin-Madison
B.S., Biochemistry
Virginia Commonwealth University School of Medicine
Doctor of Philosophy (Ph.D.), Immunology
Virginia Commonwealth University
M.S., Biology
Delhi University
B.Sc. (Honours), Biochemistry
SKILLS
ABOUT MOHIT KASHYAP
PROFESSIONAL SUMMARY: I am a dynamic regulatory professional with over 10 years of regulatory affairs experience, including regulatory strategy in the field of drug development (biologics and small molecules) across diverse therapeutic areas including orphan indications. Major accomplishments include:1. Robust portfolio of writing regulatory documents to support IND, BLA/NDA/MAA filing, orphan drug designations and accelerated approval pathways2. Project management and providing strategic regulatory advice to clients3. Mentoring and managing employees on regulatory and medical writing projects to provide a positive team experience4. Hands-on experience dealing with regulatory bodies with the ability to perform well in a fast-paced environment 5. Generating repeat business due to successful client engagement
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