Rashmith Mathew
Submission Manager - Submission Management - Regulatory Operations
- Role
- Submission Manager at Sanofi
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Rashmith Mathew
Regulatory Operations & Publishing Lead with extensive experience managing global…
Experience
Submission Manager
Mar 2025 — Present · Hyderabad, IN
Manage end-to-end regulatory submission activities for the US, Canada, and LATAM regions, ensuring timely and compliant submissions. • Utilize Veeva Vault and Insight Publisher to prepare, compile, review, and publish regulatory dossiers (eCTD, NeeS, paper). • Coordinate with cross-functional teams (regulatory, CMC, clinical, etc.) to gather, QC, and finalize submission content. • Ensure the team adheres to deadlines by assigning responsibilities, monitoring progress, and supporting task completion. • Develop and manage detailed submission timelines, identifying potential risks and implementing mitigation strategies. • Maintain up-to-date knowledge of global and regional regulatory requirements, submission formats, and health authority expectations. • Serve as a key point of contact for regulatory publishing queries and formatting standards. • Contribute to process improvements and the optimization of submission tools and workflows.
Education
Bhaskar Pharmacy College
Postgraduate Degree, Doctor of Pharmacy
Bhaskar Pharmacy College
Bachelor of Pharmacy - BPharm, Pharmacy
2014 — 2018
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