Global Clinical Regulatory Director

Scorpion Therapeutics; Jersey City (NJ); On-site; USD 120,000 - 160,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, Clinical Regulatory to lead global CTA strategy and submission activities across regions outside the US. You will work with clinical operations, CMC, and quality to ensure regulatory alignment and risk management.

The role emphasizes ex-US regulatory landscapes, GDPR/GxP compliance, and ongoing lifecycle management. A strong background in EU-CTR and ICH standards is required, with experience using CTIS/IRIS and Veeva highly desirable.

Qualifications

• 10+ years of regulatory experience or 8+ with postgraduate degree.
• Deep knowledge of international regulations (EU-CTR, ICH) and country-specific standards.
• Proficiency with regulatory submission platforms (CTIS, IRIS).
• Strong project management and communication skills.

Responsibilities

• Develop and execute international CTA strategies for global trials.
• Oversee submissions across Europe, Asia Pacific, and Latin America; lifecycle management.
• Collaborate with clinical operations, CMC, and quality teams to integrate regulatory considerations.
• Act as liaison with regulatory agencies and maintain GxP, GDPR compliance.

Skills

Regulatory submissions

Cross-functional collaboration

Project management

EU-CTR/ICH regulations

Education

Postgraduate degree preferred

Tools

CTIS

IRIS

Veeva

Microsoft Office

Job description

Scorpion Therapeutics seeks an Associate Director, Clinical Regulatory to lead global CTA strategy and submission activities across regions outside the US. You will work with clinical operations, CMC, and quality to ensure regulatory alignment and risk management.

The role emphasizes ex-US regulatory landscapes, GDPR/GxP compliance, and ongoing lifecycle management. A strong background in EU-CTR and ICH standards is required, with experience using CTIS/IRIS and Veeva highly desirable.