Shivani Vispute
Regulatory Affairs Officer @Glenmark Pharmaceuticals
Signup · Get unlimited contacts
WORK HISTORY
Regulatory Affairs Officer @Glenmark Pharmaceuticals
Navi Mumbai, IN
Preparing, compiling, and reviewing regulatory dossiers for US, EU, and Canadian markets for respiratory and topical productsHands-on experience with Modules 1, 2 (QOS), and 3 (DP & DS parts) as per CTD/eCTD formatReviewing CMC documents: Specifications, STPs, COAs, BMRs, stability reports, analytical method validations, and product development reportsConducting IIG assessments and reviewing vendor DMFs for completeness and complianceCoordinating with Formulation, Analytical, QA, Project Management, and Manufacturing teams to ensure timely submissionsExperience working with regulatory guidelines from USFDA, EMA, and Health Canada
EDUCATION
R. C. PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR
Bachelor of Pharmacy - BPharm, Pharmacy
R. C. PATEL INSTITUTE OF PHARMACEUTICAL EDUCATION AND RESEARCH, SHIRPUR
M.pharmacy , Regulatory affairs
ABOUT SHIVANI VISPUTE
As a Regulatory Affairs professional with 3 years of experience at Glenmark Pharmaceuticals, I have developed strong expertise in regulatory dossier preparation and submissions across major markets including the US, EU, and Canada. My core experience lies in handling end-to-end compilation of CTD/eCTD dossiers, particularly for respiratory and dermatology products.I have worked extensively on CMC documentation, including Modules 1, 2, and 3, and have a strong understanding of ICH guidelines, FDA/EMA regulations, and lifecycle management. I collaborate closely with cross-functional teams including formulation, analytical, and plant to ensure timely and accurate submissions.With a Master’s degree in Regulatory Affairs and hands-on knowledge of global regulatory requirements, I am now looking to contribute my skills to challenging projects in a dynamic organization and continue growing in the global regulatory space.
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.