Tanvi Dighe

- Successfully expedited the submission of ANDA dossiers and deficiency responses to regulatory authorities, ensuring compliance with eCTD standards. - Enhanced product quality and productivity by coordinating cross-functional teams for post-approval variations (CBE-30, CBE) and updating labeling submission packages.

- Spearheaded the timely approval of regulatory submissions by meticulously reviewing and compiling documents, leading to faster market entry. - Streamlined query response processes by collaborating with cross-functional teams and external stakeholders, reducing approval times. - Ensured compliance and improved product standards through the preparation of ANDA submissions, post-approval variations (PAS, CBE-30, CBE), and final approval requests for tentatively approved products.

- Maintained regulatory compliance by managing product artwork reviews and filing variations to update marketing authorizations.

- Facilitated product registration and re-registration across CIS and LATAM regions, ensuring adherence to diverse regulatory requirements. - Improved document accuracy and compliance by reviewing technical quality documents and managing applications for essential legal documents.