Harsh K. Email
Senior Manager Regulatory Affairs @ SUN PHARMA
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Harsh K. Location
- Canada
Harsh K. Work
- 2025 -now Senior Manager Regulatory Affairs @
- 2023 -2025 Regulatory Affairs Manager @
- 2019 -2023 Senior Regulatory Affairs Associate @
- 2016 -2019 Senior Regulatory Affairs Executive @
- 2014 -2016 Executive-Regulatory Affairs @
- 2014 -2014 Executive-Regulatory Affairs @ Sterling Biotech Limited
- 2012 -2013 Senior Quality Assurance Officer @
- 2011 -2012 Jr. Officer - Regulatory Affairs @
- 2010 -2010 Trainee - Projects (Research and Development) @
Harsh K. Education
- Bioinformatics Institute of India
Industry Program in Pharmaceutical Regulatory Affairs (Regulatory Affairs)
2013-2014 - SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Master of Pharmacy (Pharmaceutics and Drug Design)
2009-2011 - Hemchandracharya North Gujarat University
Bachelor of Pharmacy (Pharmaceutical Sciences)
2005-2009 - Technion - Israel Institute of Technology
Project Management
Harsh K. Skills
- Product Strategy
- Research and Development (R&D)
- OTC Markets
- Regulatory Approvals
- Regulatory Projects
- Biotechnology
- EMA
- Defining Requirements
- Product Registration
- GxP
- Quality Risk Management
- Compliance Management
- Issue Management
- Interpersonal Skills
- Team Performance
- Solution-oriented
- Problem Solving
- Analytical Skills
- Leadership
- Critical Thinking
- Project Plans
- Cross-functional Team Leadership
- Knowledge Sharing
- Coaching
- Regulatory Compliance
- Regulatory Affairs
- Regulatory Submissions
- Regulatory Requirements
- Regulatory Filings
- Regulatory Guidelines
- Global Regulatory Compliance
- Quality Management
- Quality Assurance
- Quality System
- ANDA
- Validation
- Sop
- Technology Transfer
- Generic Programming
- CTD
- eCTD
- Pharmaceutical Industry
- Standard Operating Procedure (SOP)
- Product Compliance
- Project Management
- Project Planning
- Team Management
- Drug Development
- Cross-functional Collaborations
- Regulatory Strategy Development
Harsh K. Summary
- Harsh K., based in Canada, is currently a Senior Manager Regulatory Affairs at SUN PHARMA. Harsh K. brings experience from previous roles at Taro Pharmaceuticals, SUN PHARMA and Ipca Laboratories Limited. Harsh K. holds a 2013 - 2014 Industry Program in Pharmaceutical Regulatory Affairs in Regulatory Affairs @ Bioinformatics Institute of India. With a robust skill set that includes Product Strategy, Research and Development (R&D), OTC Markets, Regulatory Approvals, Regulatory Projects and more. Harsh K. has 2 emails on RocketReach.
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