Regulatory Project Management
Senior Consultant Natalya Shtokman has more than 13 years of industry experience with a focus in regulatory program management, including multiple marketing applications (INDs, NDA, BLA, MAA and EU submissions). Natalya managed the preparation and defense of the Zynteglo® BLA and MAA and supported its Advisory Committee meeting including managing the preparation of the critical briefing book and meeting slides. Natalya also served as the program manager for the Varubi® NDA and MAA. Her skills include development and management of timelines for a variety of regulatory submissions and dashboards to track and communicate progress and ensure a timely submission. She has in-depth knowledge and expertise in managing complex submissions and cross-functional teams.
Natalya has consistently fostered close partnerships with CMC colleagues, leveraging their collective expertise to meticulously plan and track all documents and timelines associated with Module 3 of major marketing applications. Serving as a key liason, she adeptly manages the entire document process from end-to-end, ensuring seamless coordination and alignment among cross-functional teams.
Since joining Boston Biodevelopment, Natalya utilizes her regulatory program management expertise to help small to mid-size biotech clients advance their portfolios by ensuring regulatory goals and milestones are met.