Rebecca joined the Salamandra team over 12 years ago and currently serves as a Chemistry, Manufacturing, and Controls (CMC) Regulatory Affairs Manager. In her role she provides strategic support pertaining to phase-appropriate product development and the content and organization of regulatory submissions. She applies regulatory requirements and guidelines to different products, processes, and procedures, identifying deviations or gaps and proposing risk mitigation steps for consideration. In her time at Salamandra, Rebecca has been key in preparing over 20 investigational and marketing applications for the US, EU, UK, and Canada. Her experience includes small molecules and biologics, and spans a variety of dosage forms and therapeutics areas. In addition to CMC authoring support, she prepares gap analyses and contributes to FDA meeting requests and briefing packages.As part of her role, Rebecca also provides project management expertise, leveraging Salamandra’s multidisciplinary expert team to assist clients with their regulatory and technical challenges. Rebecca coordinates with clients regarding the status of ongoing projects and ensures the delivery of high-quality work products and advice. She creates and maintains project timelines and tracks deliverables against them to ensure that regulatory submissions and project deadlines are met, and any risks are identified at early stages.Before joining Salamandra, Rebecca worked in the Neurobiology and Anatomy Department at the Wake Forest University Baptist Medical Center, where she co-authored a paper on radiation-induced cognitive impairment in a juvenile rat model of cranial radiotherapy. Rebecca also spent time as a Visiting Scholar at the University of Technology, Sydney, in the Plant Functional Biology and Climate Change Departments.