Global CMC Regulatory Lead — Remote/Travel

Scorpion Therapeutics; California (MO); Hybrid; USD 150,000 - 210,000; Full time

Job summary

Scorpion Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic and operational leadership for global regulatory activities spanning development to commercialization of small molecule oral solid dosage forms.

The role leads CMC submissions (INDs, NDAs), serves as primary liaison with health authorities, and collaborates with manufacturing, formulation, analytical, and lifecycle teams to ensure compliant submissions and lifecycle management.

Qualifications

• Bachelor's in pharmaceutical sciences, chemistry, or related field.
• 8+ years in pharmaceutical/biotech regulatory affairs with significant CMC expertise.
• Experience supporting small molecule products from IND to post-approval.
• Strong knowledge of global regulatory requirements and submission processes.

Responsibilities

• Develop and execute global CMC regulatory strategies.
• Lead regulatory submissions (INDs, NDAs, MAAs, amendments).
• Serve as primary regulatory liaison for CMC topics.
• Support manufacturing, formulation, analytical, and lifecycle management activities.
• Ensure compliance with FDA, EMA, GCC, and PMDA.
• Lead health authority interactions.

Skills

Regulatory strategy

Global submissions

Cross-functional leadership

CMC regulatory expertise

Education

Bachelor's in pharmaceutical sciences/chemistry

MS/PhD/PharmD preferred

Job description

Scorpion Therapeutics seeks an Associate Director, CMC Regulatory Affairs to provide strategic and operational leadership for global regulatory activities spanning development to commercialization of small molecule oral solid dosage forms.

The role leads CMC submissions (INDs, NDAs), serves as primary liaison with health authorities, and collaborates with manufacturing, formulation, analytical, and lifecycle teams to ensure compliant submissions and lifecycle management.