Director, CMC Regulatory

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

Role: Lead global Chemistry, Manufacturing, and Controls (CMC) regulatory strategies for clinical-stage small molecule programs, supporting lifecycle management and submission activities.

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.

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, regulatory frameworks (FDA, EMA, ICH)
• excellent communication and cross-functional leadership skills

Preferred

• advanced degree (MS, PhD, PharmD), familiarity with other modalities.

High-Value: small molecule development, global regulatory submissions, lifecycle management, cross-functional collaboration.

Work setup: not specified; salary range $230K-$270K.