Seasoned Pharmaceutical Regulatory Operations Leader with over 20 years’ experience driving the evolution of the drug development process.⇨ Advances biotech products from early indication activity through launch and commercialization by managing cross-functional regulatory submission process. ⇨ Energetic and results-focused strategist who interacts across regulatory compliance departments, clinical studies, clients, and executive teams.⇨ Process-driven technologist who leverages software to achieve efficiencies and drive progress from Theory in the Lab to Proof in the Lab to market.⇨ Highly team-focused leader who empowers people, leans in for clarity, and navigates through ambiguous goals to refine processes and efficiencies.KEY DRIVERS:📌 Energetic, make-it-happen mindset📌 Bias for collaboration📌 Empowers teams📌 Process driven📌 Relationship building📌 Navigates ambiguityAREAS OF EXPERTISE:✓ Team Building ✓ Biotech Product Development✓ Project Management✓ Labeling✓ Training✓ Manufacturing Process✓ Medical Device✓ BiotechnologyTECHNICAL SKILLS: • MS Office (Word, Excel PowerPoint, Outlook, Visio, MS Project), SharePoint (Admin), Adobe Professional • EDM: Documentum, FirstDoc, ARCH, D2• Submission tool/products – Lorenz eBal, EURs, Liquent Suite, ISIToolBox• Databases: FileMaker Pro (Admin Level), Access (Admin Level)• LIQUENT Insight (integrated Regulatory Information Management platform) Manager Global Regulatory Submissions | Revenue Growth | Strategic Planning | Solution Architect | Project Management | Cross-functional Team Leadership | OQ Testing | Marketing | Publishing | Product Presentations | Electronic Systems Development | Process Change ManagementVendor Relations | Global Communication
Listed skills include Pharmaceutical Industry, Fda, Cross Functional Team Leadership, Clinical Trials, and 30 others.