Rohit Hiwrale
Assistant Manager Dra @Gland Pharma Limited
Signup · Get unlimited contacts
WORK HISTORY
Assistant Manager Dra @Gland Pharma Limited
Hyderabad, IN
Lead CMC review and preparation of ANDA submissions for US markets, ensuring 100% compliance with FDA regulations- Oversee end-to-end eCTD publishing and labeling processes, reducing submission timelines by 15%- Collaborate with R&D, QA, and manufacturing teams to align regulatory strategies and resolve complex compliance issues- Developed training materials and conducted knowledge-sharing sessions for junior team members.
EDUCATION
Savitribai Phule Pune University
Bachelor of Pharmacy - BPharm
Swami Vivekanand Academy Aurangabad
SSC
Vasantrao Naik Mahavidyalaya
HSC
Savitribai Phule Pune University
Master of Pharmacy, Regulatory affairs
ABOUT ROHIT HIWRALE
With hands-on experience in Regulatory Affairs across the pharmaceutical sector, I…
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.