Global Regulatory Affairs Director (NDA Focus), Remote

Viking Therapeutics, Inc.; United States; À distance; USD 180 000 - 280 000; Plein temps

Résumé du poste

Scorpion Therapeutics is seeking a Regulatory Affairs Director to lead global regulatory strategies and submissions, including the upcoming NDA filing. You will manage and coordinate regulatory activities across programs, ensuring compliance with FDA/ICH, GMP/GCP/GLP, and eCTD requirements.

You will partner with cross-functional teams and CROs/CMOs to craft robust regulatory strategies, oversee submissions, labeling readiness, and inspection preparedness while steering regulatory risk management

Qualifications

• Bachelor's in a scientific discipline with 8+ years in pharma/biotech, including 6+ years in Regulatory Affairs
• Hands-on experience with NDA/BLA/MAA submissions and eCTD
• Deep knowledge of FDA and ICH regulations
• Familiarity with GMP, GCP, GLP
• Experience supporting regulatory interactions and CRO/CMO collaborations

Responsabilités

• manage and execute high-quality regulatory submissions
• perform detailed document review and quality control
• maintain regulatory records
• coordinate with cross-functional teams
• develop and support regulatory strategies for clinical and manufacturing programs
• contribute to labeling and inspection readiness
• oversee external vendors

Connaissances

Regulatory affairs

FDA knowledge

GxP compliance

Cross-functional leadership

Formation

Bachelor's in life science

Outils

eCTD platforms

Description du poste

Scorpion Therapeutics is seeking a Regulatory Affairs Director to lead global regulatory strategies and submissions, including the upcoming NDA filing. You will manage and coordinate regulatory activities across programs, ensuring compliance with FDA/ICH, GMP/GCP/GLP, and eCTD requirements.

You will partner with cross-functional teams and CROs/CMOs to craft robust regulatory strategies, oversee submissions, labeling readiness, and inspection preparedness while steering regulatory risk management