Ashwin Bhosle
Regulatory Affairs Executive @MSN Laboratories
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WORK HISTORY
Regulatory Affairs Executive @MSN Laboratories
Hyderabad, IN
EDUCATION
Acharya B M Reddy College of Pharmacy
Master's degree
Rajiv Gandhi University of Health Sciences
Bachelor of Pharmacy - BPharm
ABOUT ASHWIN BHOSLE
Regulatory Professional with 1.6 Years of experience in Clinical trial applications Within the European region and India (CDSCO), Managing Clinical Trials Application.EU Region - EU-CTD to EU-CTR/CTIS.Preparing CTIS for EU Regulation.Quality checks for CTIS studies.Managing RFI’s in CTIS.Monitoring CTIS Portal for alerts.Experience in renaming, uploading, and metadata population in CTIS.India (CDSCO)-Proficient in navigating and using the CDSCO portal to apply for Export NOC licenses and other regulatory certifications in compliance with industry standards. Understand the Requirements Prepare necessary documents such as: Application form (Form 27, 51, CT 10, CT 16 for drugs, etc.) Product information and labellinga. TGA Dossier Submission (Formulation) 1. Developed and prepared comprehensive regulatory dossiers for submission to Australian authorities, ensuring compliance with local guidelines and standards. Conducted thorough reviews of documentation to guarantee accuracy and completeness. Collaborated with cross-functional teams to gather necessary data and insights. Monitored regulatory changes to maintain up-to-date submissions and strategies. Successfully facilitated timely approvals to support product launches in the Australian market.
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