Develop, maintain, and communicate integrated regulatory project plans for assigned programs, covering investigational and marketing applications, amendments, annual reports, meeting requests and briefing packages, responses to health authority information requests, labeling activities, regulatory commitments, and post-approval submissions. Reporting to the Program Management & Operations organization, the RAQA Project Manager partners closely with Regulatory Affairs, Quality Assurance, Chemistry, Manufacturing, and Controls (CMC), Clinical Development, Clinical Development & Operations, Biostatistics, Medical Writing, Pharmacovigilance, Supply Chain, Commercial, Legal, and external partners.