Our passionate team tackles complex regulatory, clinical, and safety challenges to advance global health. Explore open positions below and take the next step in your career.
Expedite adverse event ICSRs, detect drug safety signals, and ensure FDA and EMA compliance reporting.
Maintaining 100% compliance with strict 15-day expedited reporting deadlines across multi-region clinical trials.
Monitor investigative sites to verify patient safety, protocol compliance, data integrity, and Good Clinical Practice (GCP) compliance for multi-center Phase II–IV clinical trials.
Eliminating site monitoring backlogs while maintaining rigorous ICH-GCP protocol adherence.
Lead global regulatory filings for IND, NDA, and MAA submissions, oversee eCTD compilation, and coordinate with the FDA, EMA to ensure regulatory compliance.
Streamlining multi-jurisdictional dossier submissions to accelerate global drug approval timelines.