Senior Regulatory Submissions Lead

Scorpion Therapeutics; United States; On-site; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics is seeking a Senior Regulatory Submissions Lead to develop and execute global regulatory strategies across clinical trial lifecycles. You will manage submissions, ensure compliance with ICH/GCP, FDA, EU, and other global regulations, and lead CTIS activities.

You will mentor staff, drive process improvements, and provide expert guidance on complex studies including GMO and MedTech, supporting business development in a fast-paced biotech environment.

Qualifications

• 8–10 years regulatory experience with 6+ years leading complex, multi-region submissions.
• Strong knowledge of CTIS, GxP, and international regulations.
• Excellent project management, organizational, and communication skills.

Responsibilities

• Oversee preparation and submission of regulatory documents across regions.
• Act as primary regulatory contact ensuring compliance with ICH/GCP, FDA, EU, and others.
• Lead CTIS activities and coordinate cross-functional teams.
• Review and approve key regulatory and clinical documents.
• Mentor junior staff and contribute to business development.

Skills

Regulatory submissions

CTIS

GxP

Project management

Communication

Multi-region trials

Education

University degree in pharmacy, medicine, or related sciences

Tools

CTIS System

Job description

Role: Senior Regulatory Submissions Lead responsible for developing and executing global regulatory strategies and managing submissions throughout clinical trial lifecycles.

Responsibilities:

• oversee preparation and submission of CTAs, import/export licenses, and protocol amendments
• act as primary regulatory contact ensuring compliance with ICH/GCP, FDA, EU, and other regulations
• lead activities within the Clinical Trial Information System (CTIS)
• review and approve key regulatory and clinical documents
• coordinate start-up activities and maintain operational excellence
• support risk management and process improvements
• provide expert guidance on complex studies including GMO and MedTech
• mentor junior staff and contribute to business development

Requirements:

• university degree in pharmacy, medicine, or related sciences
• 8-10 years’ regulatory experience, including 6+ years leading submissions for complex, multi-region clinical trials
• strong knowledge of CTIS, GxP, and international regulations
• excellent project management, organizational, and communication skills
• proven ability to work accurately in fast-paced environments

HighValue:

• global multi-region clinical trials
• complex study management
• CTIS system expertise
• GMP/GCP/ICH compliance
• MedTech or GMO study experience
• regulatory leadership in early to late-phase studies

WorkSetup:

• not specified
• travel not explicitly mentioned