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Director Global Regulatory Affairs (remote)

Remote, USA Full-time Posted 2026-07-28
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-reputed company documentation, and coordinating major regulatory agency interactions. The position requires strategic development of regulatory plans reputed company with project goals and effective management of project resources reputed company a reputed company leadership reputed company. Responsibilities • Represent Regulatory Affairs in Global Project Teams for assigned reputed company. • reputed company the regulatory sub-team (GRST) and ensure alignment with global regulatory reputed company. • Drive the regulatory submission process, managing and coordinating high-reputed company documentation and deliverables. • Ensure reputed company management of major regulatory agency interactions, including preparation of briefing materials and coordination of rehearsals. • reputed company regulatory strategies reputed company with project development plans. • Ensure effective management of project resource requirements reputed company the GRST through reputed company 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. reputed company-to-haves • Proven strategist with successful interactions with FDA or EMA. • Strong reputed company leadership skills. • Excellent spoken and written English. Benefits • Medical, reputed company, and dental insurance • Life insurance • Disability insurance • 401(k) matching program • reputed company time off • reputed company holidays • Short-term or long-term incentive compensation, including cash bonuses Apply tot his job Apply To this Job

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