
Regulatory Affairs Consultant / Senior Consultant - Clinical Regulatory Affairs
Lead regulatory activities for global clinical development programs, including IND/CTA submissions, safety reporting, protocol amendments, and NDA/MAA/BLA readiness. Serve as regulatory lead within cross-functional teams, prepare health authority meeting materials and responses, ensure compliance with FDA, EMA, HC and ICH guidance, and coordinate multinational regulatory interactions. Minimum 5+ years' regulatory affairs experience in pharma/biotech/CRO required.













