New Consultant, Senior Regulatory Submissions Manager

Praxis’s Regulatory team is looking for an astute Senior Regulatory Submissions Manager who will oversee the operational aspects of all submissions to U.S. and international Regulatory Agencies. This person will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of submissions. They will ensure that submissions are of the highest quality and delivered on-time to meet U.S. and international regulatory requirements and company goals. Responsibilities include creating and managing submission content plans, tracking regulatory commitments, coordinating the development of submission deliverables, and managing the publication and submission of regulatory documents in eCTD format. They will also oversee the writing, review, implementation, and continuous improvement of standards, templates, and procedures related to regulatory documentation.