Sr. Manager - Regulatory Operations & Publishing
About this role
Sun Pharmaceutical Industries Ltd
Job Summary
Partners with leaders across the organization to be the ‘face of the asset’ from regulatory operations perspective. To manage the regulatory submissions strategy and operational activities across the globe submission management, data archival, data Security, data retrieval and management, Amplexor’s Regulatory Information Management System (RIMS), etc. To provide strategic and regulatory operational direction for all generic products. To collaborate with internal and external stakeholders like CMC team, supply, commercial, IPR, legal, CROs, Consultants etc to ensure smooth regulatory submissions process. To manage End to End Vendor Management activities formulate, develop and execute a comprehensive regulatory submission strategy integrating regulatory requirements.
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