Director Global Regulatory Affairs (remote)
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
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