Associate Director, Regulatory Affairs – CMC

Scorpion Therapeutics; United States; Remote; USD 180,000 - 195,000; Full time

Job summary

Scorpion Therapeutics is seeking an Associate Director of Regulatory Affairs – CMC to lead global regulatory strategies for small-molecule drug development, registration, and lifecycle management. The role involves authoring regulatory documents, overseeing CMC plans, and guiding submissions worldwide.

The candidate will engage with FDA/EMA, manage variations, and provide strategic input on manufacturing, formulation, and analytical methods.

Qualifications

• Bachelor's in Chemistry, Pharmaceutical Sciences, or related field.
• 10+ years in pharmaceutical/regulatory CMC roles with substantial experience.
• Deep knowledge of U.S. and global post-approval CMC regulatory frameworks (SUPAC, NDAs, amendments, variations).

Responsibilities

• Develop and implement CMC regulatory plans.
• Provide strategic guidance on manufacturing, formulation, and analytical methods.
• Support lifecycle changes and post-approval submissions.
• Author and review regulatory documents.
• Manage global variation filings.
• Liaise with health authorities such as FDA and EMA.

Skills

Regulatory strategy

Cross-functional collaboration

Technical writing

Education

Bachelor's in Chemistry or Pharmaceutical Sciences

MS/PharmD/PhD preferred

Job description

Role

Associate Director, Regulatory Affairs – CMC, leading global regulatory strategies for small-molecule drug development, registration, and lifecycle management.

Responsibilities

Responsibilities include developing and implementing CMC regulatory plans, providing strategic guidance on manufacturing, formulation, and analytical methods, and supporting lifecycle changes and post-approval submissions. The position involves authoring and reviewing regulatory documents, managing global variation filings, and liaising with health authorities such as FDA and EMA.

Requirements

Requirements: Bachelor's in Chemistry, Pharmaceutical Sciences, or related; 10+ years in pharmaceutical/regulatory CMC roles with substantial experience supporting marketed small-molecule products; deep knowledge of U.S. and global post-approval CMC regulatory frameworks, including SUPAC, NDAs, amendments, and variations. Preferred: advanced degrees (MS, PharmD, PhD), experience with solid oral dosage forms, and direct interactions with regulatory agencies. High-Value: expertise supporting late-stage clinical or post-market products, global CMC regulations, and lifecycle management.

Other Information

The role is based remotely with a salary range of $180,000–$195,000, with comprehensive benefits.