Suhas K.
Global Regulatory Head
- Role
- Global Regulatory Affairs Head at Umedica Laboratories Private Limited
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Suhas K.
Dynamic leader as a Global Drug Regulatory Affairs Expert, specializing in global market…
Experience
Global Regulatory Affairs Head
Umedica Laboratories Private Limited
Mar 2025 — Present · Navi Mumbai, IN
Education
USFDA
CDER Microbiology Issues: A Deeper Dive, Overview of GDUFA and Imple, Optimization of Study Data
2017 — 2017
Ashokrao Mane College of Pharmacy,Peth-Vadgaon
Master of Pharmacy in Quality Assurance Techniques
2015 — 2016
Govt College of Pharmacy Karad
B. Pharm
2004 — 2008
Smartly
Master's degree
2017 — 2017
USFDA
Certificate of Attendance- REdI Generic Drugs Forum 2018
Skills
- Regulatory Requirements
- Cmc
- Technology Transfer
- Personal Branding
- Glp
- Formulation
- Pharmaceutical Industry
- Sop
- Hplc
- Fda
- Communication
- Good Laboratory Practice (Glp)
- Regulatory Submissions
- Commercialization
- Product Launch
- Regulatory Affairs
- Abbreviated New Drug Application (Anda)
- Dissolution
- High-Performance Liquid Chromatography (Hplc)
- Gmp
- Marketing
- Anda
- U.s. Food and Drug Administration (Fda)
- Clinical Trials
- Generic Programming
- Standard Operating Procedure (Sop)
- Change Control
- Quality Assurance
- Quality by Design
- Cmc Regulatory Affairs
- Validation
- Pharmaceutics
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