Senior Regulatory Affairs Associate- CMC Biologics

Parexel International India safety services·Remote

Pay not statedMid levelFull-timeRemote

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About the role

Manage the lifecycle of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies), across various global markets Prepare and deliver regulatory submissions, including authoring and reviewing CMC components of Marketing Authorization Applications (MAAs) and Variations for different…

What you'll do

Manage the lifecycle of approved drug products, including small molecules and biologics (vaccines and monoclonal antibodies), across various global markets
Prepare and deliver regulatory submissions, including authoring and reviewing CMC components of Marketing Authorization Applications (MAAs) and Variations for different…
Handle CMC-related Health Authority queries and author responses to regulatory requests with accuracy and strategic insight
Conduct regulatory review of DMFs, batch records, specifications, and stability data to ensure compliance with applicable regulatory requirements