Scott Graves

About Scott Graves

Strategic Pharmaceutical Portfolio Manager with over 20 years of experience in regulatory submissions, process development, and leading cross-functional teams. Recognized for cultivating collaboration to bring innovative products to market, with a focus on advancing industry practices to enhance patient outcomes. Always open to new connections and opportunities to drive impactful change.Core Competencies: Team Leadership | Regulatory Strategy | Compliance | Project Management | Technical Documentation | Process Development & Training | Global Regulatory Document Management | ICH and Regional Guidance | Change Management | Risk & Issue ResolutionWith extensive expertise in managing Fast Track designation products, I specialize in streamlining the regulatory development and submission process, from initial registration through post-approval lifecycle management. Proficient in regulatory compliance systems, document management, and publishing, I thrive in optimizing processes and resolving complex compliance challenges. My experience in handling acquisitions and CTD documentation migrations ensures smooth regulatory transitions and integration.

Experience

1. Regulatory Operations Manager

   Biogen

   Mar 2025 — Present

   As a Regulatory Operations Manager at Biogen (via GForce), I lead the planning and execution of global regulatory submissions—including eCTD and non-eCTD formats—for the US, EU, Canada, and Rest of World (ROW) regions. I coordinate publishing activities across internal cross-functional teams and external vendors to ensure the accurate, compliant, and timely delivery of high-quality submissions. My role includes performing detailed quality control (QC) reviews to confirm adherence to regulatory, technical, and formatting standards. I serve as the primary regulatory operations contact throughout the product lifecycle, offering strategic guidance on submission execution and compliance. Additionally, I oversee vendor performance and contribute to continuous improvement efforts in submission processes and tools. I work extensively with regulatory technologies such as Veeva, Lorenz DocuBridge, Insight Publisher, and Documentum to manage, compile, and track submission content effectively.

Education

• Grand Valley State University

  Bachelor of Science - BS

Skills

• Pharmaceutical Industry
• Clinical Trials
• Gmp
• Ectd
• Regulatory Affairs
• Regulatory Submissions
• Ind
• Fda
• Gcp
• Drug Development
• Biotechnology
• Electronic Common Technical Document (Ectd)
• U.s. Food and Drug Administration (Fda)