Teams at Pace Labs

Leads global CMC regulatory strategies and authors regulatory submissions, including INDs, IMPDs, CTAs, amendments, and annual reports. Prepares Module 2 and 3 summaries, stability reports, comparability protocols, and responses to global health authorities. Develops compliant regulatory processes and workflows while managing multiple deliverables and timelines.

Authors Safety Data Sheets for domestic and international regulatory compliance, processes regulatory documentation and databases, manages and analyzes raw-material data, and reviews hazard communication information for accuracy. The role requires SDS authoring using 3E Generate, substance-level data cleansing, and knowledge of U.S., EU, and Great Britain requirements and labeling regulations.