As an experienced Regulatory and Quality leader with a strong track record of aligning regulatory strategies and quality requirements with business objectives, I have come to realize that this combination is what often makes or breaks small biotech companies. Being a creative and collaborative forward-thinking leader, I thrive when working with teams to develop innovative risk-based global regulatory strategies. I enjoy working directly with global regulators and having the opportunity to share the vision for and science behind our products while understanding their requirements for clinical development and commercialization.I’m known as an energetic people leader, tough but compassionate, and have been acknowledged as successful in leading globally and culturally diverse but cohesive teams. Both in my professional work and in my volunteer contributions to Gloucester Biotech Academy, I take great pleasure in mentoring talented early-career team members. When not working or traveling, I enjoy volunteering at Gloucester Biotech Academy and caring for the cats at Cape Ann Animal Aid. I love exploring new cultures with friends in far-flung locations like Malaysia, Singapore, and Austria, and introducing my kids to the world in destinations like Greece, Costa Rica, France, and Scotland. Most recently I’ve started breadmaking with my son, creating both a gluten-free and regular sour dough starter.
Listed skills include Biotechnology, Regulatory Affairs, Drug Development, Fda, and 26 others.