I am a biopharmaceutical leader with expertise in regulatory affairs (clinical, non-clinical, CMC, operations), quality (GCP, GVP, GLP, GMP), and business operations with proven success driving timelines, strategy and execution for successful outcomes. I am known for creating high-level strategies with capacity for hands-on, tactical execution. As an approachable leader, I achieve performance excellence by leveraging vision, agility, and resources with a focus on empowerment and driving results. I have served as an advisor and chief of staff to executives on operational and regulatory risks, utilizing collaboration and active listening to engender support, align priorities, and reduce risks to produce innovative solutions. I tackle complex problems in a straightforward, efficient manner while addressing root causes to propel targeted results. As a high-performing regulatory and quality professional, I find it especially meaningful to contribute to the improvement of patients’ lives through innovation, discovery, and a commitment to quality. I am energized to continue delivering value to progressive, innovative, patient-centered organizations in the biotech and pharma industry. Key Strengths:• Regulatory Strategy – Effectively progress products through all phases of drug development, resulting in filing global marketing applications for nine novel products.• Dynamic Leadership – Exceptional aptitude to lead large, high-performing teams, through mentoring, empowerment, professional development, motivational management, and transparent communication.• Operational Excellence – Deliver targeted outcomes through collaboration, alignment, agility, and results driven approach in cross-functional matrixed environments. • Vendor Management – Proven track record of effective insourcing and outsourcing strategies, optimizing plans of action to achieve best value for company through sound vendor management that achieves competitive value, flexibility, and agility, while staying within or under budget.Skills:• GCP, GVP, GMP, GLP• Regulatory affairs• Regulatory operations• Quality and compliance• Change management• Strategic planning• Resource planning• Outsourcing and insourcing • Electronic systems (RIM, eCTD)• Regulatory project management• Document management• Partner and vendor management• Forecasting and planning• Budgetary management• Global submissions standards (FDA, Health Canada, EMA, ICH, GXP, eCTD)• IND, CTA, NDA, BLA, MAA, NDS