Regulatory Affairs Project Manager/Sr. Manager

Role: Regulatory Affairs Project Manager/Sr. Manager leading cross-functional regulatory programs supporting pharma, biotech, and medical devices. Responsibilities include regulatory planning, managing NDA filings, coordinating CMC and EU MDR activities, tracking milestones, and ensuring compliance with FDA, EU, and global regulations. Collaborates with Regulatory, Quality, Clinical, R&D, Manufacturing, and Commercial teams to ensure timely deliverables and regulatory strategy execution. Requirements: Bachelor's in science, engineering, pharmacy, or related field, with 5+ years in regulatory affairs or operations within pharma, biotech, or medical devices. Strong knowledge of FDA NDA processes, CMC development, and regulatory documentation, plus experience managing complex projects and cross-functional teams. Preferred: PMP or similar certification, experience with BLA, IND, global submissions, and combination products. HighValue: expertise in FDA and EU regulatory submissions, CMC, NDA, BLA, IND, EU MDR, and global compliance. WorkSetup: Not specified; likely hybrid or onsite depending on organization.