CMC Specialist - Warren Township
1 month ago
Prepare CMC sections of BLA
Execute regulatory submission activities using Veeva Vault RIM/Docs
Ensure compliance with FDA ICH and eCTD standards Track document readiness manage timelines and resolve submission issues Support FDA information requests amendments and post-submission activities Maintain accurate compliant and inspection-ready submission documentation
Job description
, consectetur adipiscing elit. Nullam tempor vestibulum ex, eget consequat quam pellentesque vel. Etiam congue sed elit nec elementum. Morbi diam metus, rutrum id eleifend ac, porta in lectus. Sed scelerisque a augue et ornare.
Donec lacinia nisi nec odio ultricies imperdiet.
Morbi a dolor dignissim, tristique enim et, semper lacus. Morbi laoreet sollicitudin justo eget eleifend. Donec felis augue, accumsan in dapibus a, mattis sed ligula.
Vestibulum at aliquet erat. Curabitur rhoncus urna vitae quam suscipit
, at pulvinar turpis lacinia. Mauris magna sem, dignissim finibus fermentum ac, placerat at ex. Pellentesque aliquet, lorem pulvinar mollis ornare, orci turpis fermentum urna, non ullamcorper ligula enim a ante. Duis dolor est, consectetur ut sapien lacinia, tempor condimentum purus.
Access all high-level positions and get the job of your dreams.
Similar jobs
Floating Leasing Agent
6 days ago
We are seeking a dynamic and adaptable Floating Leasing Agent to join our team in the Northern Cincinnati area. · This energetic professional will serve as a versatile representative across multiple property communities, ensuring exceptional leasing experiences and maintaining hi ...
Cardiometabolic Care Specialist I
1 week ago
We create value by having a patient-centered approach and are committed to providing innovation to the benefit of our stakeholders. We focus on personal performance and development and have a culture centered on helping leaders create the conditions for people to be at their best ...
Cardiometabolic Care Specialist I
1 week ago
Cardiometabolic Care Specialist is a role that involves connecting therapies to new specialties, building cardiometabolic advocates and applying learnings that impact local markets and the organization in a cross-collaborative way. · The Position assumes responsibility for achiev ...