Rosalind Hafen has more than 20 years of experience in the pharmaceutical industry and more than 19 years of experience in regulatory CMC. She has proven expertise in the development and implementation of successful regulatory strategies in compliance with regulatory requirements as well as company objectives. Areas of expertise include management and compilation of submissions for therapeutic biological, peptide, and small molecule projects from early development stage to post-approval; regulatory strategy for expedited development programs; evaluation and interpretation of source technical documentation; and collaboration with multi-disciplinary teams to effectively plan and coordinate meetings with regulatory authorities.
Before joining Halloran, Rosalind was a Director of CMC and Regulatory Affairs at B&H Consulting Services, Inc., providing CMC regulatory support, technical writing and regulatory affairs support, regulatory strategy, and project management for IND, BLA, NDA, ANDA, and DMF submissions; original applications, amendments, responses to Agency requests, post-approval supplements and global submissions from development through the approval process. Before her position at B&H Consulting Services, Inc., Rosalind held several roles in Analytical Research and Development at Wyeth Research, including Regulatory CMC support and technical writing.
University of Colorado, Master of Arts, Molecular, Cellular and Developmental Biology (MCDB)
Colorado State University, Bachelor of Science, Biological Sciences