Senior Regulatory Affairs Program Manager

Onsite, New Jersey A fast-growing, commercially-stage biopharmaceutical company focused on next-generation cell and immunotherapy are looking for a Senior Regulatory Affairs Programme Manager to lead complex, cross-functional regulatory programmes from strategy through execution. This is a high-visibility role sitting at the intersection of regulatory strategy, programme governance, and cross-functional leadership. You'll work closely with R&D, Clinical, CMC, Manufacturing, and Commercial teams to drive global submissions, manage product lifecycles, and deliver against launch timelines. The Role You'll own the design, planning, and execution of complex regulatory initiatives — setting integrated project plans, managing milestones and dependencies, allocating resources, and proactively managing risk. Equally, you'll be the connective tissue across functions: aligning teams to regulatory strategy, keeping leadership informed, and escalating where it matters. Day-to-day this includes: Leading cross-functional governance and programme oversight across Regulatory Affairs, Quality, Clinical, R&D, Operations, Manufacturing, and Commercial Authoring and maintaining SOPs, work instructions, and standardised templates — with inspection readiness front of mind Supporting health authority interactions, audits, and regulatory inspections Mentoring junior team members and cross-functional partners on process and compliance Driving special projects and business-critical initiatives at senior leadership level Requirements 8+ years of progressive experience in a relevant field (sciences, business, or project management) 6+ years in regulatory affairs within pharma, biologics, or medical devices 5+ years managing complex, multi-regional regulatory programmes Strong working knowledge of FDA requirements and global health authority regulations Confident communicator equally effective with bench-level scientists and C-suite stakeholders Proficient in project management tools (Monday.com or similar); regulatory document management systems a plus The Opportunity You'll be joining a company with a genuine sense of mission building immunotherapies designed to harness and amplify the immune system to defeat cancer and infectious disease. The pipeline is active, the team is collaborative, and there's real scope for professional development as the organisation continues to grow. #J-18808-Ljbffr Avetix Engineering