As the Senior Vice President of Regulatory Sciences and Medical Affairs at Certara, I lead a global team of experts who provide regulatory consulting and medical writing services to biopharmaceutical, medical device, and biotechnology companies. With over 20 years of experience in the pharmaceutical industry, I have a proven track record of optimizing organizational performance, managing P&L accountability, and fostering innovation.STRATEGIC LEADERSHIP ► Extensive experience in leading global teams and managing cross-functional operations.► Skilled in strategic planning, execution, and fostering organizational growth.► Proven ability to align business processes with changing competitive environments to enhance business value.REGULATORY & CLINICAL OPERATIONS► Deep understanding of global regulatory frameworks and compliance standards.► Global leadership in drug development across all phases (I-IV) utilizing international regulatory submission strategies.FINANCIAL ACUMEN & P&L ACCOUNTABILITY ► Full P&L responsibility across various leadership roles, driving double-digit growth rates.► Strong track record of resource management and cost-effective delivery against business objectives.INNOVATION & OPERATIONAL EXCELLENCE► Focused on implementing operational excellence initiatives that protect patient safety and improve clinical trial outcomes.► Advocates for innovation, including leveraging generative AI in regulatory submissions and writing.THERAPEUTIC & MEDICAL DEVICE EXPERTISE ► Broad therapeutic experience in diverse areas such as oncology, rare diseases, inflammation, vaccines, anti-infectives, and medical devices.► Skilled in managing clinical programs for complex devices and interventional technologies.CROSS-FUNCTIONAL COLLABORATION & MENTORSHIP ► Extensive history of leading and collaborating across international teams across North America, Western Europe, APAC, and Latin America.► Commitment to developing talent and fostering a culture of accountability and innovation.BOARD MEMBERSHIPS & THOUGHT LEADERSHIP ► Active board roles in institutions like Univo IRB, American Medical Writers Association, and ECU Health Center.► Published articles and delivered webinars on cutting-edge topics such as AI and regulatory strategy.VALUES► Accountability► Collaboration ► Consistency ► Trust ► Innovation MY MOTTO“Let the data drive the decision-making.”