Remote Senior Director, Regulatory CMC Strategy

Scorpion Therapeutics; United States; Remote; USD 180,000 - 240,000; Full time

Job summary

Scorpion Therapeutics seeks a Senior Director, Regulatory Affairs CMC to lead global regulatory strategies for drug substance and product lifecycle management across small and large molecules.

You will shape CMC plans, guide submissions across development stages, and liaise with FDA, EMA, and PMDA while aligning with international guidelines. Remote work is available with occasional travel (~10%).

Qualifications

• Bachelor’s degree in a relevant field with 10+ years in regulatory CMC.
• Experience in manufacturing process development and impurity control.
• Proven ability to manage complex regulatory programs and teams.

Responsibilities

• Develop and execute regulatory CMC plans across lifecycle stages.
• Guide submissions for clinical, marketing, and post‑approval phases.
• Liaise with FDA, EMA, PMDA and other agencies; supervise regulatory meetings.
• Ensure compliance with international guidelines and best practices.

Skills

Regulatory CMC

Global regulations

Project management

Cross-functional leadership

Regulatory communications

Education

Bachelor’s degree

Advanced degree (MS/PhD/PharmD)

Job description

Scorpion Therapeutics seeks a Senior Director, Regulatory Affairs CMC to lead global regulatory strategies for drug substance and product lifecycle management across small and large molecules.

You will shape CMC plans, guide submissions across development stages, and liaise with FDA, EMA, and PMDA while aligning with international guidelines. Remote work is available with occasional travel (~10%).