Global Regulatory Strategy & Submissions Lead

Scorpion Therapeutics; United States; On-site; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics in the United States seeks a senior Regulatory Affairs leader to shape global regulatory strategy for drug development and to oversee IND/CTA activity. You will lead regulatory submissions, provide cross‑functional guidance, and mentor team members to optimize performance.

Responsibilities include risk identification, submission coordination, and ensuring regulatory commitments across regions while maintaining up-to-date knowledge of FDA/EMA/ICH guidelines and industry best

Qualifications

• 10+ years drug development with 7+ years regulatory affairs experience in Biotech/Pharma.
• Knowledge of international regulatory requirements for clinical development and post-marketing.
• Experience with clinical trial regulatory requirements and regulatory submissions.
• Experience with eCTD and electronic submissions.
• International submission/process experience a strong plus.
• Demonstrated management and leadership skills.

Responsibilities

• Formulate regulatory strategies to support program objectives and secure approvals.
• Lead regulatory affairs on assigned clinical studies and provide regulatory advice.
• Identify regulatory risks and develop mitigation plans.
• Collaborate with cross-functional teams, vendors, and partners.
• Coordinate and submit regulatory documents, filings, and responses.
• Review global regulatory submissions for consistency and quality.
• Maintain knowledge of FDA, EMA, ICH, and other guidelines.
• Ensure conformance to regulatory commitments.
• Contribute to regulatory department initiatives and best practices.
• Supervise Regulatory Affairs staff and mentor personnel.

Skills

Regulatory strategy

Regulatory submissions

eCTD

Cross-functional leadership

Global regulatory

Regulatory compliance

Mentoring

Education

Bachelor's degree in science

Advanced degree (MD/PhD/PharmD)

Tools

eCTD

Job description

Scorpion Therapeutics in the United States seeks a senior Regulatory Affairs leader to shape global regulatory strategy for drug development and to oversee IND/CTA activity. You will lead regulatory submissions, provide cross‑functional guidance, and mentor team members to optimize performance.

Responsibilities include risk identification, submission coordination, and ensuring regulatory commitments across regions while maintaining up-to-date knowledge of FDA/EMA/ICH guidelines and industry best