Pharmaceutical Regulatory Consultant

Description:

Nuvex Biotech is a growing CDMO focused on formulation optimization and drug development support. As we expand our regulatory support services, we're looking for a Regulatory Consultant with a deep understanding of drug registration, dossier preparation, and compliance strategies across local (DRAP) and global markets (US/EU/GCC preferred).

Role Highlights:

• Prepare/review CTD dossiers (Modules 1–5)
• Navigate DRAP licensing and regulatory submissions
• Advise on local and international compliance strategies (GMP/ICH/EMA/US FDA preferred)
• Provide documentation and audit-readiness support

Requirements:

• 5+ years in regulatory affairs (pharma)
• Strong grasp of DRAP, ICH, and preferably US FDA / EMA / GCC requirements
• Strong command of documentation and regulatory frameworks
• Proactive, detail-oriented, and comfortable working with lean teams