Tripti Rastogi Email
Regulatory Submission Lead @ GSK
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Tripti Rastogi Location
- Bengaluru, KA, IN
Tripti Rastogi Work
- Regulatory Submission Lead @ (September 2019 - Present)
- Manager- Regulatory Affairs and Business Continuity @ (July 2016 - September 2019)
- Sr. Executive- Regulatory Affairs @ (December 2014 - June 2016)
- Sr.Executive- International Regulatory Affairs @ (June 2012 - December 2014)
- Regulatory Affairs Executive @ (January 2010 - May 2012)
- Quality Assurance Analyst @ (August 2006 - January 2007)
Tripti Rastogi Education
- Amravati University
M.PHARMA (GOVT. COLLEGE OF PHARMACY)
2007-2009 - World Intellectual Property Organization,Geneva,Switzerland
Certification in Patent Rights
2007-2008 - Faculty Of Pharmacy Jamiahamdard
POST GRADUATE DIPLOMA IN DRUG REGULATORY AFFAIRS
2006-2007 - Bioinformatics Institute of India, New Delhi
PROFESSIONAL DIPLOMA IN CLINICAL TRIALS AND CONTRACT RESEARCH (Clinical Research)
2005-2006 - Uttar Pradesh Technical University
B.PHARMA (Pharmaceutical Sciences)
Tripti Rastogi Skills
- ACTD
- ANVISA
- Analytical Method Validation
- Biopharmaceuticals
- Brazil filings
- CMC
- CMC Regulatory Affairs
- CMC dossier
- CTD
- Career Development Coaching
- Change Control
- Clinical Research
- Coaching & Mentoring
- Common Technical Document (CTD)
- Communication
- Complaince
- Corporate Portfolio Management
- Cross company colloboration
- Cross-Cultural Communication
- Cross-functional Team Leadership
- Customs Regulations
- Dissolution
- Diversity, Equality, and Inclusion (DEI)
- Dossier Preparation
- Drug Device combination products
- Drug Regulatory Affairs
- EMA
- Electronic Common Technical Document (eCTD)
- FDA
- Formulation
- GMP
- Global Regulatory Strategy
- Global Submissions
- ICH
- ICH guidelines
- Investigational New Drug Application (IND)
- Lifecycle Management & Complaince
- MAT transfer
- Managing Associates
- Mentoring
- Microsoft Office
- Peer Mentoring
- People Development
- Personal Drive
- Pharmaceutical Industry
- Pharmacovigilance
- Process Improvement
- Product Lifecycle Management
- Project Management
- Quality System
- Regulatory Affairs
- Regulatory Compliance
- Regulatory Documentation
- Regulatory Filings
- Regulatory Guidelines
- Regulatory Intelligence
- Regulatory Requirements
- Regulatory Strategy
- Regulatory Strategy & Submissions
- Regulatory Strategy Development
- Regulatory Submissions
- Risk Mitigation & Process Transformation
- Site Initiation
- Site Management
- Sop
- Stakeholder Management
- Strategic Planning
- Submission Tracking
- Team Management
- Teamwork
- Time Management
- Validation (Drug Manufacture)
- Variation Reduction
- Veeva Vault
- Veeva Vault, Power BI & Smartsheet
- Veeva Vaut
- Clinical Trials
- eCTD
- Regulatory
- NDA
- Oncology
- GCP
- Pharmaceutics
- ANDA
- 21 CFR Part 11
- IND
Tripti Rastogi Summary
- Tripti Rastogi, based in Bengaluru, KA, IN, is currently a Regulatory Submission Lead at GSK. Tripti Rastogi brings experience from previous roles at SUN PHARMA, Alembic Pharmaceuticals Limited and SIMPEX PHARMA PVT LTD.. Tripti Rastogi holds a 2007 - 2009 M.PHARMA in GOVT. COLLEGE OF PHARMACY @ Amravati University. With a robust skill set that includes ACTD, ANVISA, Analytical Method Validation, Biopharmaceuticals, Brazil filings and more. Tripti Rastogi has 2 emails on RocketReach.
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