Shail Shah, MS, MBA, RAC

Vice President of Regulatory Affairs

Shail Shah serves as the Vice President of Regulatory Affairs of ARMR Sciences
Inc., where he leads the company’s engagement with health authorities and
guides its global, program-wide regulatory strategy and execution. Shail
coordinates with cross-functional teams and external CROs to deliver integrated
development plans, timelines, budgets, and risk mitigations, all while
maintaining strong interfaces with regulators and translating regulator feedback
into actionable program direction. Shail brings over 17 years of pharmaceutical
and biotechnology product experience along with a strong vaccine regulatory
background to the ARMR Sciences team.

Prior to joining ARMR, Shail served as Senior Director, Regulatory Affairs at
Curevo Vaccines, leading global regulatory strategy for a herpes zoster vaccine
and directing multi-jurisdictional submissions and health authority interactions
to advance through multiple rounds of Phase 2 trials and toward Phase 3 and
global approvals.

Earlier, Shail served as Manager and Senior Manager of Regulatory Affairs at
Emergent BioSolutions, where he conducted a successful collaboration with
BARDA on Anthrax vaccine programs which resulted in the successful approval
of a BLA. Shail’s work on national stockpile and CBRN-type products was essential
in contributing to strategic readiness and development for national security
objectives. Before Emergent, Shail’s work at Accord Healthcare on products
including oral solids, injectables, biosimilars, and small-molecule programs
across multiple therapeutic areas resulted in 25 successful approved ANDA
submissions and 2 approved NDA submissions.

Shail holds an MBA in Strategy and Leadership from the Kenan-Flagler Business
School at the University of North Carolina at Chapel Hill, an MS from Texas
Tech University, and a Bachelor of Technology (BTech) from Dr. D.Y. Patil
University in India. He maintains an active Regulatory Affairs Certification in
Pharmaceuticals.