Milind Suresh Damare
Senior Manager-ii Global Regulatory Sciences - Cellular Therapy @百时美施贵宝
Signup · Get unlimited contacts
WORK HISTORY
Senior Manager-ii Global Regulatory Sciences - Cellular Therapy @百时美施贵宝
Hyderabad, IN
Global Regulatory CMC lead for Cell Therapy project, responsible for original submissions, post approval life cycle maintenance in US, EU and other regulated markets. Handling Regulatory filing strategies, change controls/deviations assessments ensuring compliance to Regulatory requirements and product quality.
EDUCATION
Savitribai Phule Pune University
Bachelor of Pharmacy, Pharmaceutical sciences, Pharmacology, Pharmaceutics, Medicinal Chemistry
National Institute of Pharmaceutical Education and Research
M.Tech (Pharm), Pharmaceutical Biotechnology, Biocatalysis, Fermentation technology, Molecular biology.
IPMA Pune
Diploma course , cGMP
SKILLS
ABOUT MILIND SURESH DAMARE
I am a Global Regulatory Affairs professional with 15+ years of experience in Biologics, Cell Therapy and Biosimilars portfolio, specializing in CMC regulatory submissions across early development, late-stage, and post-approval phases. My expertise includes regulatory strategies during product development and regulatory filings like BLA/MAA submissions, EU variations, USFDA PAS, and other lifecycle maintenance activities for NBEs, Cell Therapy, Biosimilars.I have had experience in compiling briefing books and scientific advice packages, supporting BPD, pre-submission, and pre-IND meetings as part of product development strategies. My role has also included driving regulatory sciences behind process development, process characterization, process comparability, biosimilarity assessments, and regulatory assessments of changes and deviations. I have supported cGMP evaluations, site audits, and compliance with quality systems across global manufacturing facilities.Recognized with multiple awards for successful product authorizations and timely clinical trial approvals supporting successful product launches, I combine regulatory expertise with leadership, mentoring, and effective cross-functional collaboration.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.