Director, Regulatory Project Management

Global Regulatory Project Manager We are seeking a Director, Regulatory Project Manager to lead the end-to-end planning and execution of global regulatory submissions to Health Authorities. In this role, you will translate regulatory strategy into actionable plans, drive cross‑functional alignment, and ensure submission deliverables are completed on time, with quality, and in compliance—even in fast‑moving, high‑impact situations. You will partner closely with Regulatory Leadership and Submission Management, lead submission task forces, proactively manage risks and dependencies, and provide clear, confident communication to stakeholders up to senior leadership. What You Will Do Plan and track global regulatory deliverables for submissions worldwide (e.g., CTA/IND, MAA/NDA/BLA, major HA interactions such as Scientific Advice/meetings). Build and maintain integrated project plans, timelines, and critical path views; ensure clarity on scope, deliverables, owners, and dependencies. Lead and run Submission Task Forces for initial applications; co‑chair international submission taskforces supporting global rollout of new assets. Drive issue resolution and "crisis" intervention to protect timelines; set up enhanced hyper‑care support for critical submissions. Own risk and stakeholder management: surface risks early, communicate impacts transparently, and align mitigation plans with key partners. Coordinate resource and budget planning for Regulatory activities; consolidate budget demand and serve as key contact to Global Project Management and project controlling. Strengthen execution through continuous improvement of project management tools, templates, and ways of working to meet Health Authority requirements. Act as a senior advisor/mentor, influencing across functions and contributing to operational and strategic decisions in regulatory project management. What Success Looks Like You consistently deliver complex submissions with strong governance, clear decisions, and disciplined execution—enabling teams to move faster, reduce risk, and meet global Health Authority expectations. Minimum Requirements and Qualifications Advanced degree (e.g., PhD, PharmD, MD, or equivalent). At least 6 years of project management experience in drug development and regulatory affairs. Demonstrated ability to lead in a matrixed environment and coordinate multi‑disciplinary teams. Strong written and spoken English; proficiency in additional languages is a plus. Location This is an onsite role based in our Billerica, MA facility requiring an onsite presence at least 3 days per week, Tuesday-Thursday. Pay Range $135,300 - $202,900. The offer range represents the anticipated low and high end of the base pay compensation for this position. The actual compensation offered will be determined by factors such as location, level of experience, education, skills, and other job‑related factors. Position may be eligible for sales or performance‑based bonuses. Benefits offered by the Company include health insurance, paid time off (PTO), retirement contributions, and other perquisites. #J-18808-Ljbffr