Associate Director, Clinical Regulatory

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

Associate Director, Clinical Regulatory

Role: Associate Director, Clinical Regulatory at a biopharma focused on innovative molecular imaging platforms, responsible for managing global clinical trial applications (CTAs) and ensuring regulatory compliance ex-US. Responsibilities include developing and executing international CTA strategies, overseeing submission processes across multiple regions including Europe, Asia Pacific, and Latin America, and maintaining lifecycle management. The role involves collaborating with clinical operations, CMC, and quality teams to integrate regulatory considerations, acting as liaison with regulatory agencies, supervising quality systems compliance with GCP and GDPR, and proactively managing regulatory risks. Requirements: 10+ years of relevant experience (or 8+ with postgraduate degree), deep knowledge of international regulations such as EU-CTR, ICH, and country-specific standards, proficiency with submission platforms like CTIS or IRIS, and strong project management and communication skills. Preferred qualifications include experience with Veeva, Microsoft Office, and electronic regulatory systems. High-value specifics: focus on ex-US regulatory landscapes, global clinical trials, and compliance with GxP, GCP, GDPR. Work setup requires a minimum of 3 days onsite in Jersey City, NJ, with extensive cross-functional collaboration across clinical and regulatory teams.