Global Regulatory Affairs Lead - Drug & Biologics Submissions

Remotedxb in Dubai seeks an experienced Regulatory Affairs professional to oversee preparation, review, and submission of non-clinical and clinical regulatory documents. You will coordinate with global teams and lead FDA meetings, preparing briefing materials.

You will mentor staff, evaluate changes affecting registrations, and ensure compliance for INDs, NDAs, and BLAs. Proficiency with TrackWise, Veeva, ICTD, and MS Office is required.