Yogananth M.pharm.rac Email & Phone Number
Vice President-Global Regulatory Affairs @ Kashiv BioSciences LLC
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Yogananth M.pharm.rac Location
- India
Yogananth M.pharm.rac Work
- Vice President-Global Regulatory Affairs @ (May 2025 - Present)
- Head-Regulatory Affairs and Quality Assurance (Cell and Gene therapy) @ (December 2021 - May 2025)
- Head - Global regulatory Affairs and DQA - Biologics and Biosimilars @ (January 2019 - December 2021)
- General Manager - Global regulatory affairs (Biologics) @ (April 2018 - December 2018)
- Assistant General Manager - Global Regulatory affairs(Biologics and biosimilars) @ (November 2017 - April 2018)
- Senior Manager - Global Regulatory Affairs (Biosimilars, CMC) @ (March 2016 - November 2017)
- Lead Regulatory Affairs (Biosimilars) @ (January 2012 - March 2016)
- Senior Executive International Regulatory Affairs - Biosimilars @ (October 2010 - January 2012)
- Assistant Manager - Biologics Regulatory Affairs @ Shasun Pharmaceuticals Ltd - Biologics Unit (August 2005 - October 2010)
Yogananth M.pharm.rac Education
- Indian Institute of Management Ahmedabad
Leadership development Program (Senior Leadership Development)
2021-2021 - The Tamilnadu Dr.MGR Medical University
M.Pharm (Pharmaceutical Biotechnology)
2003-2005 - Institute of Pharmaceutical Technology, Annamalai University
Bachelor's Degree (Pharmacy)
1996-2000
Yogananth M.pharm.rac Skills
- Global Regulatory affairs
- Regulatory Compliance
- Quality Assurance
- ADC
- Regulatory Strategy Development
- Monoclonal Antibodies
- Biopharmaceuticals
- Regulatory Affairs
- Project Management
- biologics
- Pharmaceutical Industry
- Validation
- Biotechnology
- Technology Transfer
- Regulatory Submissions
- FDA
- GMP
- Regulatory Requirements
- Medical Devices
- CAPA
- U.S. Food and Drug Administration (FDA)
- Cell Culture
- Pharmacovigilance
- Quality Control
- V&V
- Good Laboratory Practice (GLP)
- Corrective and Preventive Action (CAPA)
- Good Manufacturing Practice (GMP)
- Change Control
- Clinical Trials
- Quality Management
- Microsoft Office
- Microsoft Excel
- Microsoft PowerPoint
- CTD
- ANDA
- Orphan Drugs
- CMC Regulatory Affairs
- CMC development
- Regulatory Intelligence
- Pharmaceutical Manufacturing
- GxP
- International regulatory affairs
- biologics CMC
- Biosimilar regulatory affairs
- Novel biologics
- CAR-T
- Cell and Gene therapy
- ATMP
Yogananth M.pharm.rac Summary
- Yogananth M.pharm.rac, based in India, is currently a Vice President-Global Regulatory Affairs at Kashiv BioSciences LLC. Yogananth M.pharm.rac brings experience from previous roles at Immuneel Therapeutics Private Limited, Zydus Group, Freyr Solutions and Intas Pharmaceuticals Ltd. (Biopharma Division). Yogananth M.pharm.rac holds a 2021 - 2021 Leadership development Program in Senior Leadership Development @ Indian Institute of Management Ahmedabad. With a robust skill set that includes Global Regulatory affairs, Regulatory Compliance, Quality Assurance, ADC, Regulatory Strategy Development and more. Yogananth M.pharm.rac has 2 emails and 1 mobile phone numbers on RocketReach.
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