Crystal has developed regulatory, strategic, and technical expertise in clinical development as well as extensive knowledge of the international regulatory landscape of FDA, HC, and EMA throughout her involvement in global development programs over the past 10+ years with Salamandra. She manages projects across several therapeutic areas, with an emphasis on development of clinical study protocols, reports, and other related documents for Phase 1 through Phase 3 studies as well as preparation of the clinical sections of INDs, CTAs, and marketing applications. In addition, she liaises with regulatory authorities on behalf of clients and supports regulatory meetings, including preparation of meeting request letters and briefing packages. She has also completed courses held by the Regulatory Affairs Professional Society (RAPS) and Center for Professional Innovation and Education (CfPIE) on European Regulatory Procedures and Good Clinical Practice, and she is a key resource for Salamandra’s internal team and clients for knowledge in these areas.
Over the course of her time with Salamandra, Crystal has had the benefit of growing with the company while utilizing the skills and knowledge gained in biology, chemistry, and technical writing during her studies. During her first few years at Salamandra in a research role and subsequent years involved with project management, she gained significant experience in many areas that she is currently involved with or manages (e.g., data gathering and analysis, clinical development and management, and global regulatory submissions). This has equipped her with a strong foundation that allows her to effectively work with Salamandra’s talented group of scientists, research associates/assistants, and submissions team.
Working at Salamandra, Crystal loves the endless opportunity for intellectual stimulation and growth with creative, flexible, independent thinkers open to exploring new ideas and taking on challenges. It is motivating because it has not only given her the knowledge base that allows her to draw on prior experience, which is invaluable in the world of consulting, but it also applies to many areas outside of work. It has been, and continues to be, a truly unique experience that she appreciates.
Crystal is passionate about food and wine – she loves exploring cultures through their traditional cuisines and winemaking, eating out at creative restaurants, or simply connecting with friends and family over a great meal.
What is the story behind the image in your letter?
“One of my favorite things about traveling is seeing beautiful, unique architecture – and I especially love interesting doors. The photograph behind my letter is the door of a small building on a cobblestone street in Hondarribia, a charming, colorful fishing village close to where I live in Spain’s Basque Country. The various shades and textures caught my eye, inspiring me to see more of the world!”