Mangala comes to Biologics Consulting with over 3 years of regulatory submission experience. She is proficient with assembling the applications & submissions of NDA/ANDA/IND drugs to FDA using eCTD software and lifecycle maintenance via the FDA Electronic Submissions Gateway.
She previously worked with Exela Pharma Sciences, LLC as Senior Regulatory Associate. Her primary responsibilities were authoring, reviewing, coordinating and submitting the CMC, clinical data for NDA/ANDA/supplements/annual reports along with publication & validation of all eCTD submissions. She has experience communicating with regulatory agencies on pre-submission strategies, potential regulatory pathways, follow up of submissions under review and obtaining product approval. She was also responsible for reviewing product promotional materials, labeling, batch records, specifications and test methods for compliance with applicable regulations and policies and coordinate internal & FDA audits. Over the course of 3 years, she was directly responsible for the submission and lifecycle management of over 25 products.
In her previous role, Mangala was instrumental in deployment, data migration (from CD to eCTD) & user acceptance testing of the eCTD software. She directly contributed to the enhancement of this system by coordinating with the software development team to define functional, design & UAT requirements.
Prior to Exela, Mangala worked with Bio-Pharm Inc as a Quality and Compliance Associate where she was responsible for preparing, issuing and reviewing Batch & Master Production / Control Records. She performed QA in-process checks to ensure batch quality consistency. Her responsibilities also included raising & documenting planned/unplanned/incidental deviation, CAPA and Change Controls. She was also responsible for preparing certificate of analysis for release of commercial distribution batches.
Master of Science in Drug Regulatory Affairs | Long Island University, Brooklyn | May 2015
Bachelor of Pharmacy | SPP School of Pharmacy, NMIMS University, Mumbai, India| May 2013