Job Description
About the position The Director of Global Regulatory Affairs will represent Regulatory Affairs in Global Project Teams, leading the regulatory sub-team and ensuring alignment with global regulatory strategies. This role involves driving the regulatory submission process, managing high-quality documentation, and coordinating major regulatory agency interactions. The position requires strategic development of regulatory plans aligned with project goals and effective management of project resources within a matrix leadership framework. Responsibilities • Represent Regulatory Affairs in Global Project Teams for assigned projects. • Lead the regulatory sub-team (GRST) and ensure alignment with global regulatory strategy. • Drive the regulatory submission process, managing and coordinating high-quality documentation and deliverables. • Ensure optimal management of major regulatory agency interactions, including preparation of briefing materials and coordination of rehearsals. • Develop regulatory strategies aligned with project development plans. • Ensure effective management of project resource requirements within the GRST through matrix leadership. • Participate in cross-functional and Global Regulatory Affairs initiatives. Requirements • Advanced degree with at least 5 years of relevant experience. • Minimum of 3 years of recent oncology experience. Nice-to-haves • Proven strategist with successful interactions with FDA or EMA. • Strong matrix leadership skills. • Excellent spoken and written English. Benefits • Medical, vision, and dental insurance • Life insurance • Disability insurance • 401(k) matching program • Paid time off • Paid holidays • Short-term or long-term incentive compensation, including cash bonuses Apply tot his job