Akhilesh Nagaich, PhD in

Akhilesh Nagaich, PhD

Login to view DISC.
Director of Regulatory Affairs (Head CMC) at Kashiv BioSciences LLC
📍 Washington DC-Baltimore Area, United States

Dr. Akhilesh Nagaich is a Regulatory and CMC Executive and the Founder of FDAInsight, LLC. Leveraging over 20 years of experience, including a past role as an FDA Principal Investigator, he advises biopharma companies on complex regulatory submissions, CMC development, and GMP compliance. He holds a Ph. D. from the University of Allahabad.

His work includes serving as an expert witness in high-stakes pharmaceutical litigation involving patents and regulatory compliance. His deep scientific background is demonstrated through publications on gene expression, epigenetics, and the molecular structure of DNA.

Read the full overview →
Experience
14 Years
Current Role
Director of Regulatory Affairs (Head CMC)
Job Level
Leadership
Location
Washington DC-Baltimore Area, United States
Personality Overview

How Akhilesh shows up

Communication Style
Decision Approach
Work Preference

Behavioral traits and communication patterns that shape how this person evaluates opportunities, builds trust, and makes decisions in professional settings.

Login to view personality overview.
Priorities

Topics Akhilesh cares about

Regulatory Strategy
He advises biopharma and life sciences organizations on FDA regulatory pathways, including IND, NDA, BLA, and ANDA submissions.
CMC & GMP Compliance
A core part of his professional focus involves Chemistry, Manufacturing, and Controls (CMC) development and ensuring Good Manufacturing Practice (GMP) compliance.
+5 more topics Login to view topics
Career

Work history

12-2018 - 11-2019
Director of Regulatory Affairs (Head CMC)
Kashiv BioSciences LLC
9-2017 - 10-2018
Senior Manager Regulatory Affairs
Emergent BioSolutions
2017
Founder and Principal Consultant
FDAInsight, LLC
4-2015 - 8-2017
Senior Industry Consultant
The FDA Group, LLC
4-2015 - 7-2015
Regulatory Affairs Manager
Medefil, Inc.
In the press

Media appearances

No media yetWe could not find public media appearances for this person.
Education
Ph.D
University of Allahabad
Social presence
in
Behavioral profile

DISC profile (public)

DISC behavioral profile

Dominance, influence, steadiness, and calculativeness scores with guidance on how this person prefers to communicate and decide.

Login to view DISC.

More profiles

Discover additional public profiles from our index.

Aarnav Singh
Aarnav Singh
Full-stack Developer
Premier Energies Limited
 Chithra Battini
Chithra Battini
Deputy General Manager HR
Premier Energies Limited
 YU-TAI CHANG
YU-TAI CHANG
Quality Control Inspector
Artivion, Inc.
 Raja Sekher Reddy Pusapti
Raja Sekher Reddy Pusapti
DY-CONSTRUCTION MANAGER
Premier Energies Limited
Unlock the full playbookSee exactly how to sell to Akhilesh. Free, 10 seconds.