Profile

Dr. Mark De Rosch

Nightstar Therapeutics

Contact Details

Nightstar Therapeutics

Bio

Senior regulatory affairs professional with 25+ years experience in global regulatory strategies for clinical, nonclinical, and CMC in multiple therapeutic areas (renal, hemophilia, cystic fibrosis, auto-immune, oncology/hematology, musculoskeletal, pain, radiopharmaceuticals) for small molecules and biologics. In-depth knowledge of US, EU and Japan regulatory requirements, including preparation and submission of NDAs, BLAs, MAAs, INDs, CTAs, Pediatric Study Plans (PSP), Paediatric Investigational Plans (PIP), Fast Track Designations, and Orphan Drug Designations. Proven experience working with global regulatory agencies, including preparation for and conduct of meetings, to align global regulatory strategy with corporate and commercial goals. Effective leader of cross-functional teams with excellent communication and presentation skills. Experienced in building effective Regulatory teams. Dedicated to mentoring junior staff.

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