A.Vinay Kumar

Mylan/Viatris

06.2021 - 06.2022

Sharing CTD & ACTD files of products with clients to facilitate approval in their regions
Conducted research and analysis to support regulatory submissions and address regulatory queries
Utilizing various tools such as MS Word, MS PowerPoint, Excel, Acrobat DC, and internal trackers at Viatris
Responsibilities demonstrate involvement in regulatory compliance, client communication, and the use of essential tools for documentation and tracking within the pharmaceutical regulatory landscape
Collaborated with cross-functional teams to ensure timely submission of regulatory documents and adherence to regulatory requirements
Assisted in the preparation and maintenance of regulatory submissions, including INDs, NDAs, BLAs, and variations
Participated in regulatory strategy meetings to provide input on product registration and approval processes
Prepared and delivered presentations to internal stakeholders and external clients on regulatory topics and project updates
Developed visually engaging and informative materials using MS PowerPoint to effectively convey regulatory strategies, timelines, and achievements during meetings and updates
Collaborated with internal teams to address regulatory issues, resolve discrepancies, and implement corrective actions as needed
Participated in regulatory agency meetings, teleconferences, and correspondence to facilitate product approvals and address regulatory inquiries
Maintained comprehensive and organized regulatory files and databases to facilitate document retrieval, audit readiness, and compliance monitoring
Provided guidance and support to cross-functional teams on regulatory requirements, submission timelines, and documentation standards.

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