Aditi Joshi Email & Phone Number

St. Charles, Il, Us

As a Manager at Pfizer, I spearheaded lifecycle management for a diverse portfolio of pharmaceutical products. My role was pivotal in managing global regulatory filings and executing strategies for PAS, CBE-30, and CBE-0 submissions across international markets. I thrived in leading cross-functional teams, liaising with global counterparts, and ensuring compliance with regulatory requirements. My leadership in establishing CMC regulatory strategies and proactive management of documentation and submissions has been a cornerstone in maintaining product compliance and supporting business objectives.

At Meitheal Pharmaceuticals, I played a key role in driving the regulatory affairs for ANDA applications, achieving first-pass approvals and managing over 250 submissions. I effectively balanced original ANDA and post-approval submissions while ensuring compliance with FDA guidance. My collaboration with third-party manufacturers and internal teams was instrumental in maintaining regulatory alignment and efficient communication with the FDA.

Greater Chicago Area

Greater Chicago Area

In my tenure as an Associate Scientist at Fresenius Kabi, I specialized in analytical method validation using techniques like HPLC and GC, contributing significantly to pharmaceutical drug product quality. I was responsible for ensuring the precision of analytical support for various processes, including raw material release testing and formulation development. My focus on maintaining compliance with GMP and FDA regulations, along with my contributions to documentation and interdepartmental collaboration, underlined my commitment to upholding the highest standards of quality and regulatory compliance.

Bachelor'S Of Science

Associate Of Science