Senior Regulatory Affairs Associate- CMC Biologics

About the role

We are seeking a Senior Regulatory Affairs Associate - Biologics to join our team in a remote capacity at India. As a regulatory affairs professional, you will drive the lifecycle management of approved biopharmaceutical products, ensuring compliance with global regulatory requirements and advancing patient access to innovative treatments.

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
• Author CMC components of Annual Reports, renewals, and GMP-related submissions, including site registrations and regulatory documentation

What you need

• 5–9 yrs of experience
• Regulatory affairs
• Chemistry
• GMP
• Documentation
• Communication
• Any graduate