Prashant Dighe Email & Phone Number

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Co-Founder and Principal Regulatory Consultant | AI-Enabled Solutions Lead @ (July 2026 - Present)
General Manager - Regulatory Affairs (EU, ROW) @ Aculife Healthcare LTd. (August 2025 - July 2026)
General Manager @ Aculife Healthcare Limited, Ahmedabad (January 2025 - January 2026)
Senior Manager I - Regulatory Affairs (US, EU, CA and AU) @ (April 2022 - August 2025)
Senior Manager - II (US and EU) @ (March 2017 - March 2022)
Senior Manager Regulatory Affairs @ Sun Pharmaceutical Industries Ltd, Vadodara (January 2017 - January 2025)
Regulatory Manager (US, EU and ROW) @ (July 2014 - March 2017)
Regulatory Affairs Manager @ (January 2014 - January 2017)
Assistant Manager (EU and US) @ (July 2010 - July 2014)
Regulatory Affairs Manager @ Mylan Lab Ltd (January 2010 - January 2014)
Executive (EU) @ (April 2010 - July 2010)
Sr. Officer (US, EU and RoW) @ (August 2008 - March 2010)
Regulatory Affairs Executive @ Indoco Remedies Ltd, Mumbai (January 2010 - January 2010)
Regulatory Affairs Officer @ Micro Labs Ltd, Corporate R&D, Bangalore (January 2008 - January 2010)
Sr. Officer (ROW) @ (January 2007 - August 2008)
Senior Quality Assurance Officer @ Wockhardt Limited, Aurangabad (January 2007 - January 2008)

AISSMS
M Pharm (PG)
2004-2006
AISSMS College of Engineering
Master of Pharmacy (Pharmacy)
2004-2006
PRCOP, Savitribai Phule Pune University
B. Pharma
2000-2004
P.R.C.O.P. College of Pharmacy. Pravaranagar
Bachelor of Pharmacy (Pharmacy)
2000-2004
RCOP Inc.
Bachelor of Pharmacy
Sangamner College, Sangamner
XII
Stuyvesant High School Alumni Association, Inc.
X

Global regulatory submission for all type of dosage forms (pharmaceutical and biological products)
510(k)
AI-Enabled Solutions
Abbreviated New Drug Application (ANDA)
Annual Reports
Biologicals
Capsules
Change Control
Communication
Compilation
Compliance Monitoring
Coordination Of Projects
DMF
Database Design
Distribution Management (Marketing)
Documentation Practices
Drug device combination, complex generics and Medical devices
ECMp
Global regulatory strategist
Injections
Interviewing
Labeling (US, EU and CA)
Labels
Life cycle management for global markets
Management
Market Evaluations
Medical Devices
Microsoft Excel
New Drug Application (NDA)
Peptides, devices, liposomes, combination products
Pharmacy Education
Principal Regulatory Affairs strategist
Product Labeling
Product Launch
Product Registration
Project Coordination
Quality Assurance
Registration
Regulations
Regulatory Advice
Regulatory Affairs
Regulatory Audits
Regulatory Compliance
Regulatory Development
Regulatory Requirements
Regulatory Strategy
Regulatory Strategy Development
Regulatory Submissions
Regulatory Training
Regulatory affairs, complex generics, NDA, ANDA, MAA, liposomes, peptides, device, combination products
Research Evaluation
Revisions
Solid Oral Dosage Forms
Strategic Sourcing
Strategy
Tablets
Team Facilitation
Technical Reports
Technical Writing
Third Party Reporting
Training and Development (HR)
US, EU, CA market

Prashant Dighe, based in Vadodara, GJ, IN, is currently a Co-Founder and Principal Regulatory Consultant | AI-Enabled Solutions Lead at RegAlign Consultancy. Prashant Dighe brings experience from previous roles at Aculife Healthcare LTd. , Aculife Healthcare Limited, Ahmedabad and SUN PHARMA. Prashant Dighe holds a 2004 - 2006 M Pharm in PG @ AISSMS. With a robust skill set that includes Global regulatory submission for all type of dosage forms (pharmaceutical and biological products), 510(k), AI-Enabled Solutions, Abbreviated New Drug Application (ANDA), Annual Reports and more. Prashant Dighe has 1 emails and 1 mobile phone numbers on RocketReach.