Regulatory Project Management
Senior Consultant Daria Stoltz has more than 25 years of experience in technical operations and program management across development functions from pre-clinical through NDA submission. Daria has an extensive background managing complex projects and large diverse teams developing small molecules, cell and gene therapies, and biologics across a broad range of therapeutic areas, including lung transplantation, invasive aspergillosis, rare disease, oncology, neurological disease, pulmonary arterial hypertension, pain, and vaccines.
Daria’s technical background began in analytical development and includes leading CMC teams, and developing and maintaining Quality Management Systems, including SOP development. She has also served as project manager or program lead for clinical development programs. Daria’s regulatory project management experience includes NDA, IND, CTA, and IMPD submissions and meetings including INTERACT.
Since joining Boston Biodevelopment, Daria leverages her expertise in technical operations, product development, and project management to provide clients with seasoned program leadership and regulatory project management with a focus on technical submissions.