Remote: Associate Director, Global CMC Regulatory Affairs

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

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.