Director, Regulatory Affairs Advertising Promotion Operations

Key Responsibilities

• Serve as the system owner for the enterprise-wide software system of review through strategic collaboration with commercial, med affairs, and legal stakeholders to support company objectives, launch readiness, and organizational scalability.
• Build and optimize operational the MLR infrastructure, governance frameworks, and business processes across the review committee.
• Aid in the development, training, and maintenance of review committee SOPs, submission standards, and governance documentation.
• Maintain operations technologies and platforms for system of review, 2253 archival and organizational platforms.
• Collaborate with medical affairs, commercial, and other stakeholders on project plans and timelines, ensuring operational preparedness for the launch of VDPHL01.
• Develop efficient and cost-effective 2253 process including strategic review of external and internal systems options for submission of materials through the eCTD gateway.
• Serve as the day-to-day lead for Ad Promo operations including coordination for all material submissions, planning and calendaring.
• Facilitate all review committee meetings, office hours, prioritization, and launch planning meetings.
• Drive continuous process improvement initiatives through KPI development, analytics, reporting dashboards, and operational metrics.

Candidate Profile

• Bachelor's degree or minimum of 10+ years of experience within biotech, pharmaceutical, or regulated healthcare industries.
• Demonstrated experience standing up enterprise-wide PRC processes, systems, governance, and operational frameworks to support scalable review and launch readiness.
• Experience in preparing and submitting promotional materials to the FDA on form 2253 through eCTD.
• Demonstrated leadership of review committee processes and promotional compliance.
• Experience with Veeva Vault, Smartsheet, and other project management platforms.