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Shwetha Tiwari
Shwetha Tiwari
Regulatory Affairs Specialist
Shwetha Tiwari is a Regulatory Affairs Specialist with over 8 years of experience in global pharmaceutical regulatory operations, specializing in CMC documentation, dossier compilation, and product lifecycle management. She has extensive expertise in managing international submissions, handling variation filings, coordinating health authority responses, and supporting regulatory audits across multiple regions. Skilled in working with cross-functional teams including QA, QC, R&D, and Production, Shwetha ensures regulatory compliance with ICH, CTD, GMP, and country-specific guidelines. Known for her strong documentation accuracy, process ownership, and team mentorship, she contributes to efficient product registration, compliance assurance, and continuous regulatory improvement.
FORMERLY AT
Himalaya Wellness Company
LOCATION
Bengaluru, India
AVAILABILITY
Full Time
Skills
Adobe Acrobat
CDSCO / DCGI Processes
CORELDRAW
Cross-Functional Data Coordination
CTD Dossier Preparation
CTD Guidelines
CTD Modules
ENOVIA
FSC
GDP
GMP
GMP / Regulatory Standards
HIDOMS
ICH
reyr SUBMIT
+3 More
Work Experience
Regulatory Affairs Specialist
Himalaya Wellness Company
Aug 2018 – Present
- Develop CMC strategies and manage global registration, variation, and renewal submissions.
- Handle dossier compilation, updates, post-approval variations, and product lifecycle management (PLCM).
- Coordinate responses to health authority queries and product complaints. ‘
- Support international regulatory audits and oversee artwork reviews based on country guidelines.
- Mentor junior associates on regulatory systems and compliance processes.
TECHNOLOGIES
Freyr SUBMIT, ENOVIA, HIDOMS, Adobe Acrobat, CORELDRAW, TrackWise, CTD Guidelines, ICH, GMP, GDP
Regulatory Affairs Executive
Ultra Laboratories Pvt. Ltd.
Sept 2017 - July 2018
- Prepared and reviewed CMC documentation (Modules 2 & 3).
- Supported deficiency responses and lifecycle maintenance activities.
- Managed change notifications and communications with health authorities.
- Reviewed validation and stability documentation to maintain compliance.
- Tracked change control activities using TrackWise.
TECHNOLOGIES
TrackWise, CTD Modules, Stability & Validation Documentation, GMP / Regulatory Standards
