Senior Regulatory Affairs Associate- CMC Biologics
RemoteFull-timeMid levelPosted over a month ago
Mid-level pharma role at Parexel International India safety services. Remote.
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
What you need
- Regulatory affairs
- GMP
- Documentation