Global CMC Regulatory Lead, Small Molecules

Scorpion Therapeutics; South San Francisco (CA); On-site; USD 230,000 - 270,000; Full time

Job summary

Scorpion Therapeutics in South San Francisco is seeking a Lead Global CMC Regulatory Strategist to guide clinical-stage small molecule programs through lifecycle management and regulatory submissions.

You will develop and execute CMC strategies from IND/CTA to NDA/MAA, oversee documentation quality, respond to agency questions, and ensure inspection readiness across global teams. Strong regulatory affairs expertise and cross-functional leadership are essential.

Qualifications

• Bachelor’s in life sciences.
• 10+ years in biotech/pharma regulatory affairs.
• Strong experience with small molecules, IND/CTA, NDA/MAA processes.
• Deep understanding of CMC development and regulatory frameworks (FDA, EMA, ICH).
• Excellent communication and cross-functional leadership skills.

Responsibilities

• Develop and execute CMC strategies from IND/CTA to NDA/MAA.
• Provide guidance on manufacturing changes, comparability, and control strategies.
• Prepare and author CMC sections and briefing documents; oversee submissions, document quality, and compliance; support inspection readiness.

Skills

Regulatory affairs

Cross-functional leadership

Communication skills

Education

Bachelor’s in life sciences

Advanced degree (MS, PhD, PharmD)

Tools

CMC development

Job description

Scorpion Therapeutics in South San Francisco is seeking a Lead Global CMC Regulatory Strategist to guide clinical-stage small molecule programs through lifecycle management and regulatory submissions.

You will develop and execute CMC strategies from IND/CTA to NDA/MAA, oversee documentation quality, respond to agency questions, and ensure inspection readiness across global teams. Strong regulatory affairs expertise and cross-functional leadership are essential.