Regulatory Affairs Lead for Clinical Programs & Submissions

Scorpion Therapeutics; United States; On-site; USD 201,000 - 234,000; Full time

Job summary

Scorpion Therapeutics seeks a senior Regulatory Affairs lead to shape global regulatory strategies for clinical programs. You will guide cross-functional teams, manage regulatory risks, and oversee high-quality IND/CTA submissions, NDAs, and amendments while aligning with FDA/EMA/ICH and GXP standards.

The role requires extensive experience in biotech/pharma regulatory affairs, strong communication skills, and the ability to coordinate multiple priorities across internal and external partners.

Qualifications

• Bachelor’s degree required (preferably scientific); advanced degree is a plus.
• 8+ years drug development; 5+ years regulatory affairs in biotech/pharma.
• Knowledge of global regulatory requirements (FDA, EMA, ICH) and GXP.

Responsibilities

• Contribute to development and execution of regulatory strategies for assigned programs; serve as regulatory lead for assigned clinical studies.
• Identify potential regulatory risks and develop mitigation approaches.
• Provide regulatory guidance to cross-functional product development teams (study operating teams and workstreams).
• Lead preparation, review, and timely submission of high-quality, compliant regulatory documents (INDs, CTAs, amendments; NDAs, supplements).
• Contribute to internal regulatory process improvements (processes, operating guidelines, templates, best practices).
• Support preparation for health authority interactions, including briefing packages and response documents.
• Participate in agency communications and help track commitments and action items.
• Stay current with evolving global regulatory requirements and assess potential program impact.
• Ensure regulatory activities comply with applicable regulations and company procedures.

Skills

Regulatory affairs

Cross-functional collaboration

Regulatory strategy

Project coordination

Written/verbal communication

Education

Bachelor's degree

Advanced degree preferred

Job description

Scorpion Therapeutics seeks a senior Regulatory Affairs lead to shape global regulatory strategies for clinical programs. You will guide cross-functional teams, manage regulatory risks, and oversee high-quality IND/CTA submissions, NDAs, and amendments while aligning with FDA/EMA/ICH and GXP standards.

The role requires extensive experience in biotech/pharma regulatory affairs, strong communication skills, and the ability to coordinate multiple priorities across internal and external partners.