Candice Montagna, MS, RAC

SAN DIEGO, CA Candice Montagna, MS, RAC ASSOCIATE PRINCIPAL CONSULTANT, REGULATORY AFFAIRS

Candice has a 22-year Regulatory Affairs career in the biopharma industry with an emphasis on late-stage development. She has expertise in Regulatory strategy, Regulatory execution, and Regulatory operations for pharmaceuticals and biologics. She has extensive experience in developing the highest quality investigational (IND/CTA) and marketing (NDA/BLA/MAA) submissions in eCTD format for global health authority approval. She has proficiency in Regulatory designations (Orphan, Fast Track, Breakthrough Therapy, and Priority Review) as well as Real-Time Oncology Review, Rolling Review, and Accelerated Approval. She has been the Regulatory lead for 30+ FDA meetings (Types A-C, including Pre-IND, EOP1, EOP2, Pre-NDA/Pre-BLA, and BTDR Preliminary Advice) and 1 EU Scientific Advice meeting with MHRA (UK) across multiple therapeutic areas (rare oncology, immuno-oncology, cardiovascular, anti-infective, and insomnia). 

Before joining Halloran, Candice held senior Regulatory Affairs positions at Pfizer, Somaxon Pharmaceuticals, and Optimer Pharmaceuticals, bringing multiple drugs to market and giving her balanced experience in small, medium, and big pharma. 

Education:

San Diego State University, Master of Science (M.S.), Regulatory Affairs 
San Diego State University, Bachelor of Science (B.S.), Business Administration, Major: Management, Minor: Communication 
Regulatory Affairs Certification (RAC) by the Regulatory Affairs Professional Society (RAPS) with a focus on US regulations