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Technical Writer (Regulatory Affairs)
Job
Entegee, Inc.
Saint Louis, MO (In Person)
Full-Time
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Job Description
Regulatory affairs project role focused on submissions, project timelines, deliverable tracking, electronic submission tools, and FDA and global regulatory compliance. Job Requirements Bachelor's degree in Life Science or related field 3+ years of regulatory affairs experience Experience with regulatory submissions Experience with regulatory publishing 3+ years of project management experience Knowledge of FDA regulations Knowledge of global regulatory requirements Experience working with cross-functional teams Experience working with international teams Experience maintaining project databases Experience coordinating regulatory project timelines Preferred Skills Project management experience in pharmaceutical or healthcare environments eCTD experience Experience using electronic submission tools Experience tracking regulatory milestones Experience tracking department metrics Experience supporting global regulatory submissions Experience managing incoming regulatory requests Experience reviewing documentation for quality and compliance Job Responsibilities Coordinate regulatory submissions Manage regulatory project timelines Track deliverables, milestones, and department metrics Maintain project databases Manage incoming regulatory requests Support cross-functional teams during regulatory projects Support mitigation of resource conflicts Ensure compliance with FDA and international regulatory requirements Facilitate use of electronic submission tools Communicate across global teams Ensure regulatory documentation quality Support successful regulatory approvals through submission coordination and project tracking