The Senior Clinical Trial Manager (Sr. CTM) is a key member of Clinical Operations and will closely partner with the Clinical Program Manager and the EMEA Clinical Trial Manager in the oversight and conduct of the EMEA region. Assists Clinical Program Manager with set-up of regional CRO and other vendors. Oversees and assists the EMEA CTM with the following: day-to-day contact with counterpart at CRO and/or trial site. Leads EMEA regional regulatory submission strategies.
Syner-G BioPharma Group is seeking a Regulatory Affairs Consultant to support a global pharmaceutical client in Chemistry, Manufacturing, and Controls (CMC), focusing on post-approval regulatory submissions, providing strategic regulatory guidance and operational support to ensure compliance with FDA, EMA, and global regulatory requirements.
Contribute to the development and implementation of regulatory strategies aligned with corporate goals and timelines. Assist in planning and coordinating regulatory submissions and interactions with health authorities. Prepare, review, compile, and archive regulatory documents, including IND applications, Biologics License Applications (BLA), Regenerative Medicine Advanced Therapy (RMAT) designations, and Marketing Authorization Applications (MAAs).