Cynthia Andersen Email and Phone Number

Regulatory liaison for women’s infertility and endometriosis treatment projects. Plan and lead interdisciplinary teams regarding formal meetings with FDA for early to late stage clinical development and CMC programs. This includes facilitating development of FDA meeting packages for FDA INTERACT, PIND, and pre-BLA meetings and coordinating BLA/NDA dossier development plus subsequent FDA communications during FDA review.Spearhead labeling development for new BLAs in collaboration with key stakeholders and SMEs. Regulatory lead for early stage (drug development and preclinical) LBP project US Regulatory Intelligence lead for local and global compliance teams.

Regulatory CMC and Labeling & Promotional Lead for Eagle Pharmaceuticals , a growing pharma company specializing in improving parenteral drug formulations and refining existing treatments.

Development and management of a US Regulatory CMC and Labeling department for an exponentially expanding generic pharma company

Provide regulatory approval/launch and promotional strategies for new drug and device projects US, Health Canada and LATAM. Extensive CMC background. Projects included Miralax, Zegerid, Claritin Chewables, Claritin Grape Syrup, Chlortrimeton, Dr. Scholl's devices

FDA liaison for new topical drug approvalsUnder my direction, my project teams obtained approval of 15 ANDAs for topical generic products within one year (8 of which were first generics) approximately 6 months ahead of internal target approval dates.