Sandeep Kumar R
Regulatory Submission Publisher
- Role
- Assistant Manager at Biocon Biologics
- Location
- Bengaluru, IN
- LinkedIn followers
- 500 followers
About Sandeep Kumar R
I Sandeep Kumar, I am having 8+ years of experience in Regulatory Submission…
Experience
Assistant Manager
Sep 2022 — Present · Bengaluru, IN
Managed the preparation and submission of regulatory filings for biologic products, including BLAs, INDs, and variations with EMA, Canada region.• Hyper-linking, bookmarking, review of dossier, publishing, and validation of submission and dispatching the submissions from gateways.• Experience in Original Application, CMC supplements, Amendments, Annual reports, Labeling supplements, PSUR, Pediatric Investigation Plan, Scientific Advice, MAA Renewal filings, Variations filing, Supplement filing, Non-Clinical and Clinical study reports, Investigators & Safety Submissions publishing for US, EU, GCC, and Canada in eCTD format. • Implemented electronic document management systems (e.g, Veeva Vault) to streamline regulatory submissions and tracking processes.• Assisted in the preparation and submission of labeling components for regulatory filings (e.g, INDs, NDAs), ensuring completeness and adherence to regulatory guidelines.• Supported labeling revisions and updates based on regulatory feedback and internal review processes.• Responsible for the preparation and maintenance of Structured Product Labeling (SPL), validating SPL with back end technical aspects, submitting for eDrug Listing• Collaborated with cross-functional teams (Regulatory Affairs, Clinical, Labeling) to facilitate timely submissions and regulatory approvals.• Establishment Registrations, Obtaining NDC’s for new Products, Renewal of DUNS • Provided guidance on document formatting, submission requirements, and regulatory compliance issues to internal stakeholders.• Assisted CMC team in word formatting for authoring M3 sections• Contributed to cross-functional teams to resolve regulatory issues and ensure compliance throughout the product lifecycle.
Education
HKES College of Pharmacy
Bachelor of Pharmacy (B.Pharm.)
2011 — 2015
Infant Jesus College of PUC
Pre University
2009 — 2011
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