Regulatory Project Management

Regulatory Project Management

Requirements

• Bachelor’s degree or higher
• A minimum of 7 years of experience in regulatory project management
• Hands-on experience with NDA filing is a must
• Oncology Regulatory PM experience

Responsibilities

• Project Planning and Execution of Regulatory Submissions (e.g., IND, CTA, NDA, MAA, IMPD, simplified dossiers, briefing packages, RFI, exploratory IND)
• Develop and maintain project timelines and schedules
• Define project scope, objectives and deliverables
• Create and manage project plans, including resource allocation and task assignments
• Monitor project progress, identify potential issues and escalate to stakeholders as needed
• Cross-functional Communication
• Communicate project status and progress to internal and external stakeholders
• Collaborate with Program Management to ensure regulatory timelines are in alignment with company program timelines and expectations.
• Manage expectations and address concerns of stakeholders
• Collaborate with cross-functional teams to ensure project success
• Documentation and Reporting
• Prepare and maintain regulatory submission trackers
• Document project milestones and report progress against team, department and corporate goals
• Provide regular updates on project progress and status to management and cross-functional teams

Preferred Qualifications

• Experience with all phases of clinical development (eIND, IND, CTA, MAA dossiers)
• Demonstrable proficiency in project timeline and Gannt chart software (eg, OnePager, MS Project, Smartsheet), MS Office (eg, Outlook, Word, PowerPoint, Excel, and Teams), Adobe Acrobat Pro and video conferencing
• Radiopharmaceutical experience