Regulatory Affairs Project Manager
July 22
🏡 Remote – New York
Description
• Develop and maintain overall BLA integrated project timelines • Develop and maintain dashboards to monitor critical gating items • Provide PM support for FDA meeting interactions • Support CMC Regulatory in development of timelines • Ensures BIMO inspection readiness • Identifies potential critical issues, constraints, and risks • Drives decision making processes and escalates issues • May communicate to senior leadership
Requirements
• Prior experience in BLA or NDA regulatory filings • Understanding of must-haves vs. nice-to-haves for regulatory filings • Prior experience as a project manager • Strong attention to detail • Propensity to document at the right level • Able to identify roadblocks and provide direction to teams • Applies scientific principles to assess issues • Requests and collects relevant information • Analyzes data, establishes facts, and draws valid conclusions
Apply Now
