Ashwini Nawale

About Ashwini Nawale

I am a passionate individual with a Master\'s degree in Regulatory Affairs for Pharmaceuticals, Medical Devices, and Biologics from Northeastern University. I am highly skilled life sciences professional with a strong background in research and development. With a proven track record in delivering innovative solutions and driving scientific advancements, I am passionate about pushing the boundaries of scientific knowledge to improve patient outcomes.I possess more than 8 years of experience in the pharmaceutical industry & Medical Device, I have developed and applied skills in safety aspects of drug products, including pharmacovigilance, quality assurance, and regulatory submissions. I have successfully handled regulatory activities in safety variations, new registrations, and maintenance of marketing authorizations in developed and emerging markets, working with global teams and health authorities.In my previous role at Abbott Laboratories, I was responsible for end-to-end labelling process, ensuring the alignment and implementation of the company core data sheet (CCDS), USPI, and EU SmPC. I also managed regulatory dossiers modules 4 and 5 and their respective sections in modules 1 and 2. I received multiple awards for my contributions to labelling compliance activity and audit preparation for MHRA inspection.Core competences :Regulatory: ICH Guidelines (GMP, GLP, ISO ISO13485), IND forms (1571, 1572), eCTD Modules, GHTF labeling guidance & Regulation model, Recalls, De Novo, PMA, NDA, BLA, ANDA, 510(K) license, PMA,MDR,UKCA maintenance activities for IND & NDA; REMS, DSUR, Med watch forms, QMS Design controls, CAPA, Quality Inspections

Experience

1. Regulatory Affairs Project Lead

   Abbott

   Sep 2024 — Present · CA, US

Education

• Shreemati Nathibai Damodar Thackersey (SNDT) Women's University, Mumbai

  Bachelor's Degree, Pharmacy

• Atomic Energy Central School

  SSC

• Northeastern University

  MS, Regulatory Affairs Drugs, Medical Devices & Biologics

• Atomic Energy Junior College - India

  HSC, Science