VP, Regulatory Affairs
Kim Raymer has more than 27 years of professional experience in regulatory affairs, with deep expertise in chemistry, manufacturing, and controls (CMC). Kim has extensive experience with the regulatory CMC aspects of investigational and marketed drug products for both small molecules and biologics. She has worked on early development programs, clinical trial applications, global marketing authorizations, and post-approval life cycle management. Kim has substantial experience developing regulatory CMC strategy and often serves as the lead author of regulatory CMC submissions. In addition to regulatory CMC expertise, Kim also contributes to the overall regulatory strategy for early development programs, health authority agency interactions, and regulatory project management.
Before joining Halloran, Kim was in a leadership role within the regulatory CMC group at ARIAD Pharmaceuticals Inc., focusing on small molecules with oncology indications. Before ARIAD, she held various positions in regulatory CMC at Genzyme Corporation where she contributed to both small molecule and biologic programs. Kim began her professional career at Pfizer Inc. in small molecule process development and contributing to regulatory submissions and technology transfer documents.