Minir Shah

About Minir Shah

With a robust background at Sandoz, my focus is on spearheading regulatory labeling…

Experience

1. Regulatory Affairs - Labeling

   Sandoz

   Mar 2017 — Present

   Applying strategic thinking and regulatory knowledge for responding to FDA requests- Creating and Maintaining SPLs for products in alignment with changing technical elements- Managing and tracking the review process for labeling components to ensure timely submissions to the FDA- Identifying and initiating labeling changes for USP updates, RLD updates, and updates for new regulatory requirements, including PLR format- Archiving all labeling documents in accordance with internal procedures- Responsible for managing time-sensitive labeling approval process by collaboration with multiple organizations- Identifying the related regulatory responsibilities and taking the lead to achieve successful completion- Prioritizing launch labeling components readiness by interacting with concerned division at various locations- Ensuring labeling approval with outside vendors using Track Wise and confirming the accuracy of final labeling- Interacting with the different departments for accuracy and correctness of regulatory labeling.