Praxis's Regulatory team is seeking a Consultant for approximately 7-8 months, specifically a Senior Regulatory Submissions Manager to oversee the operational aspects of submissions to U.S. and international Regulatory Agencies. They will manage the planning, tracking, coordinating, compiling, QC, submitting, and archiving of submissions in order to ensure the submissions are of the highest quality and delivered on-time.
The Manager, Regulatory CMC is responsible for supporting Chemistry, Manufacturing, and Controls (CMC) regulatory activities related to the development and commercialization of the company’s product. This role works closely with cross-functional teams, including Manufacturing, Quality Assurance, Quality Control, and Research, to compile and maintain high-quality regulatory submissions. The Manager will assist in the preparation of CMC content for INDs/CTAs and amendments, assess change controls for regulatory impact, and help ensure compliance with applicable US and global regulatory requirements.