Avani Shah
Regulatory Consultant II
Avani is a seasoned regulatory affairs professional with over 8 years of experience in the pharmaceutical industry, specializing in regulatory strategy, compliance, and team leadership. Proven ability to drive regulatory submissions and approvals, manage cross-functional
teams, and develop innovative regulatory strategies.
Avani has led the authoring, management, and compilation of CMC sections for INDs, IND Amendments, NDAs, IMPDs, Annual Reports, and Development Safety Update Reports (DSURs). Planned and prepared post approval submissions e.g., CMC amendments and annual reports, ensuring timely submissions. Acted as a Regulatory Project Manager, laying out submission timelines and tracking progress towards project completion. Actively contributed to the development and implementation of regulatory strategy and timelines for all the assigned client projects and programs, resulting in successful regulatory approvals.
Avani received a master’s degree in Regulatory Affairs and Health Policy at MCPHS University in 2016.
Avani is skilled in Regulatory compliance and strategy, project management, cross functional collaboration and document management.
Avani Shah's Recent Articles
Accelerating Cancer Treatment Approvals: The FDA’s Real-Time Oncology Review (RTOR) Program
In the ever-evolving landscape of cancer treatment, timely access to effective therapies is crucial. The FDA’s Real-Time Oncology Review (RTOR) program is a groundbreaking initiative designed to expedite the review process for oncology drugs and biologics ensuring that patients receive…