Tiffany Leemkuil

BILLINGS, MT Tiffany Leemkuil CONSULTANT, REGULATORY AFFAIRS

Tiffany Leemkuil has ten years of regulatory affairs, project management, and regulatory operations experience supporting pre-IND, IND, and NDA/BLA stage programs, including a recently FDA-approved NDA. She has experience working with CDER and CBER spanning numerous therapeutic areas including oncology, addiction and pain, live biotherapeutic products, diabetes, ophthalmology, and neurology. Tiffany is also adept with regulatory strategies such as RTOR, Orphan, Fast Track, and Breakthrough designations.  At Halloran, Tiffany provides regulatory project management and strategy support, timeline establishment and management, and submission execution. 

Before joining Halloran, Tiffany was a consultant for emerging life science clients. She provided regulatory affairs and operational support as an Assistant Regulatory Affairs Project Manager for US and EU submissions. She published numerous Pre-IND and IND submissions as well as IND lifecycle submissions (e.g., CMC and protocol amendments, information requests, investigator updates, and annual reports/DSURs) via FDA ESG. She also assisted in the development and organization of CTAs for the EU. Before working in a consulting role, Tiffany worked in clinical research assisting with on-site regulatory-related activities such as IRB and IACUC submissions and maintenance in hospital networks. Tiffany has a Bachelor of Science in Biology from the University of Idaho.