Chetan Pagare

Regulatory Affairs Executive @Asence Pharma Private Limited

Vadodara, IN

Prepare, compile, and review regulatory submissions (CTD/eCTD formats) for product registrations, renewals, and variations as per regional and international guidelines.Ensure timely submission and follow-up of applications with regulatory authorities.Maintain up-to-date knowledge of changes in drug regulatory environments and communicate impacts to relevant departments.Coordinate with cross-functional teams (R&D, QA, QC, Manufacturing, Supply Chain) to gather necessary documentation.Maintain regulatory documentation, databases, and records in compliance with internal procedures and regulatory standards.Assist in handling product labelling, artwork approvals, and packaging compliance.Respond to regulatory queries and deficiencies from health authorities in a timely manner

Savitribai Phule Pune University

Bachelor of Pharmacy - BPharm, Pharmacy

Savitribai Phule Pune University

Bachelor of Pharmacy - BPharm