Associate Director, CMC Regulatory Affairs - Small Molecules

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

Role: Associate Director, CMC Regulatory Affairs, providing strategic and operational leadership for regulatory activities related to small molecule drug products, primarily oral solid dosage forms, from development through commercialization.

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 global agencies including FDA, EMA, GCC, and PMDA;
• and lead health authority interactions.

Requirements

• 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.

Preferred

• advanced degrees (MS, PhD, PharmD), experience with lifecycle management of oral solid dosage forms, and familiarity with biologics or combination products.

High-Value

• focus on small molecule oral solid drugs, global regulatory submissions, lifecycle management, cross-functional collaboration, and experience with major international regulatory agencies.

Work Setup

• remote with some travel (~10%), onsite presence required in San Diego, face-to-face interactions essential.